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Unread 09-13-2012, 02:03 PM   #1
NancyB
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Default Orexo's bupe tablet Zubsolv in pharmacies now - Updated 10.2013

This one is a pill that "...demonstrated an accelerated dissolve time, has a smaller tablet size and an improved taste, resulting in a strong preference in comparison with the Suboxone tablet.'

The product name? Zubsolv, of course. lol

Hopefully with more products coming out, the cost for the medication will go down.


http://www.orexo.com/en/Investor-Rel...s/?guid=695381

Swedish specialty pharmaceutical company Orexo announced today the submission of a New Drug Application for Zubsolv™ (OX219) to the US FDA

Orexo is the first company to submit a New Drug Application (NDA) for a novel combination product of buprenorphine and naloxone for treatment of opioid dependence, a condition affecting over two million Americans.

The development of Zubsolv (OX219), a product comprising buprenorphine and naloxone based on Orexo’s proprietary sublingual drug delivery technology, has progressed well and faster than originally anticipated. A total of four clinical studies were completed in support of the filing, along with a CMC product stability program covering two independent manufacturing sites.

“Today´s FDA submission, the third in our short history, constitutes a substantial milestone. Very few companies of our size and lifetime have ever managed to complete three development programs, Edluar™, Abstral® and now Zubsolv. Orexo will potentially be the first company to offer an alternative treatment option to Suboxone®, which reached sales of USD 1.3 billion in 2011 and continues to exhibit steady growth of more than 15 per cent annually.

The earlier submission is expected to be of major commercial importance, as it provides a potential launch of Zubsolv in the third quarter of 2013 – ahead of other branded competitors. In our clinical studies Zubsolv has demonstrated an accelerated dissolve time, has a smaller tablet size and an improved taste, resulting in a strong preference in comparison with the Suboxone tablet. Our market insights indicate that these properties, which are important product characteristics for particularly sublingual therapies, will be important drivers for the market uptake of the product and we estimate peak sales to reach USD 500 million annually”, says Anders Lundström.

Opioid dependence is increasingly recognized as a major health problem in the US, with over two million Americans affected, costing the society an estimated USD 25 billion in related health care cost. The Zubsolv (OX219) treatment option will, once approved by the FDA, be directed towards the authorized specialized prescribers of Suboxone in US, of which 5000 physicians account for about 90% of all US prescriptions.

“With the NDA submission for Zubsolv (OX219) five months ahead of schedule, we will now finalize our US commercialization plans for the brand to ensure that the substantial value of Zubsolv (OX219) will be realized”, continues Anders Lundström, CEO of Orexo.

For further information, please contact:
Anders Lundström, President and CEO
Tel: +46 706-67 22 66, E-mail: anders.lundstrom@orexo.com

About Orexo
Orexo AB is an emerging specialty pharma company developing improved treatments using proprietary drug delivery technology. Orexo’s expertise is within the area of reformulation technologies and especially sublingual formulations. The company has a portfolio of revenue-generating EU and US approved products currently marketed under licence and a pipeline of several reformulations of approved compounds for areas of unmet medical need. Orexo also has collaboration projects with several international pharma companies. Orexo AB, with its headquarters in Sweden, is listed on NASDAQ-OMX. The largest shareholders are Novo A/S and HealthCap.

About Zubsolv™ (OX219)
Zubsolv is a novel sublingual formulation of buprenorphine and naloxone using Orexo’s extensive knowledge in sublingual technologies. Zubsolv is intended for maintenance treatment of people suffering from opioid dependence. Through application of its proprietary technologies Orexo has increased the bioavailability of the active ingredient, accelerated dissolve time, reduced tablet size and improved taste resulting in a preference of Zubsolv in comparison with Suboxone tablet. Zubsolv has the potential to be the first new entrant into a USD 1.3 billion market, with more than two million patients suffering from opioid dependence and where a majority of patients are not adequately treated today. Market potential for Zubsolv is at peak estimated at USD 500 million in sales annually.

For more information about Orexo please visit www.orexo.com

Orexo is required under the Financial Instruments Trading Act to make the information in this press release public. The information was submitted for publication at 1 pm CET on September 6, 2012.
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Unread 09-14-2012, 08:46 AM   #2
MicheleJ
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Hi Nancy,
When do you think this new brand would be available?
Also, would that lower the price of regular Suboxone tablets? I take tablets, & just a few months ago they became the "non preferred" brand, & my co-pay went up. I'm glad at least they are covered, though, or else I could never afford them. I guess the new strips must now be the "preferred" brand. Do you think? I've never tried the strips. I probably won't, unless the tablets would no longer be covered, at all.
Thanks, Nancy.
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Unread 09-14-2012, 09:16 AM   #3
NancyB
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Hi Michele, this is from the press release:

"The earlier submission is expected to be of major commercial importance, as it provides a potential launch of Zubsolv in the third quarter of 2013 – ahead of other branded competitors."

I don't know how insurance companies decide what is a preferred brand, but it looks like the strips must be with your insurance now. I wonder if the price of the tablets went up higher than the strips and that's what prompted it? Interesting question though.

Nancy
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Unread 11-19-2012, 08:37 AM   #4
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Update on Zubsolv:

FDA accepts Orexo’s Zubsolv NDA for review
http://www.news-medical.net/news/201...or-review.aspx


FDA has informed Orexo (STO:ORX) that the Zubsolv New Drug Application (NDA) has been accepted for review, and that the Prescription Drug User Fee Act (PDUFA) action date will be July 6, 2013.

Orexo submitted the application for approval of Zubsolv on September 6, 2012. Following a preliminary assessment of completeness, the application is now entering the substantive review stage. Orexo expects Zubsolv to be approved 10 months after submission to the FDA, in July 2013. The launch of Zubsolv is planned for September 2013.

"Today's notice from the FDA is yet another step for Orexo towards becoming a fully integrated specialty pharmaceutical company with a US commercial presence. We have a good chance of becoming the first company to offer an alternative treatment option to Suboxone®, which is today the leading product in the US market for the treatment of opioid dependence," says Anders Lundström, Orexo's President and CEO.

Opioid dependence is increasingly recognized as a major health problem in the US, with over two million Americans affected, costing society an estimated USD 25 billion in related health care costs. Zubsolv will, once approved by the FDA, be directed towards authorized specialized prescribers. The opioid dependence market currently served with Suboxone is estimated to reach sales of USD 1.5 billion in 2012 and continues to display steady growth of more than 15 percent per year.

To differentiate Zubsolv from competitors and maximize the commercial potential, comprehensive clinical development and product life cycle management programs have now been initiated. The primary focus of these programs is to fully explore and document the therapeutic potential of Zubsolv in initiating treatment of opioid dependence, and to document treatment adherence and patient experiences during maintenance treatment with Zubsolv. In addition, Orexo will be completing documentation of further dose strengths as well as providing one additional flavour of Zubsolv to complement the current product offering.

Source: Orexo
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Unread 11-28-2012, 07:33 AM   #5
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More news on Zubsolv:

New study by Orexo emphasizes importance of Zubsolv product characteristics in direct comparison to Suboxone Film

http://in.finance.yahoo.com/news/stu...071200720.html

UPPSALA, Sweden--(BUSINESS WIRE)--
Regulatory News:
Orexo AB (Orexo)(ORX.ST) today announced the successful completion of an acceptability study comparing Zubsolv (OX219) to Suboxone Film, which is the leading product for treatment of opioid dependence. The study shows that 9 out of 10 participants would choose Zubsolv over Suboxone Film for a daily treatment.

Zubsolv is a new sublingual tablet formulation of buprenorphine and naloxone for treatment of opioid dependence. The product is based on elements of Orexo’s proprietary sublingual platform technology, which comprises enhanced trans-mucosal absorption of active pharmaceutical ingredients, mucosal micro-particle adhesion, as well as taste masking, formulated in a rapidly disintegrating sublingual tablet. These features are important attributes for pharmaceuticals administered sublingually. Improvement in taste and dissolve time has previously been associated with an enhanced treatment adherence in opioid dependent patients(1).

A previous preference study, which compared Zubsolv to the Suboxone Tablet, demonstrated that 8 out of 1o participants preferred Zubsolv. The current study was undertaken to assess the acceptability of Zubsolv in comparison to the Suboxone Film. The study was a cross-over trial in which 28 participants were given either Zubsolv or Suboxone Film in random order on separate study days. Key results indicate that Zubsolv was preferred by more than 8 out of 10 of the participants on all acceptance parameters tested, i.e. overall acceptability, taste masking, after taste experience, mouth-feel, and ease of administration. The study also confirmed a fast dissolve time for Zubsolv. When asked specifically about which product the participants would choose for a daily treatment, 9 out of 10 participants reported they would select Zubsolv.

Zubsolv has been submitted and has been accepted for review by the FDA, with approval projected for July 2013 and the US launch being planned for September 2013.

"The positive results in this study are very encouraging, and confirm that Zubsolv is well positioned to take a substantial share of the growing USD 1.5 billion market for treatment of opioid dependence. I am confident that the higher acceptability of Zubsolv will translate into an improved treatment adherence, and that it will aid in attracting a higher proportion of the five million patients currently suffering from opioid dependence into treatment. ” said Anders Lundström, President and CEO of Orexo.

On the basis of the results from this study, a comprehensive clinical program designed to fully explore and document the therapeutic potential of Zubsolv is being initiated. The first wave of studies will cover treatment initiation, treatment adherence and patient experiences during treatment of opioid dependent people with Zubsolv, and will help further differentiate Zubsolv from its competitors.

(1) Reckitt Benckiser Pharmaceuticals H1, 2012 presentation. July 2012
About the study The study was a cross-over trial performed in healthy adult subjects under Naltrexone block, in which 28 participants were given either Zubsolv or Suboxone Film in random order on separate days. The study compared a number of important product attributes including overall product acceptability, taste, aftertaste, mouth feel and ease of drug administration. Each product attribute was scored by all study participants using a visual analog scale (VAS).

About Zubsolv
Zubsolv is a novel sublingual formulation of buprenorphine and naloxone using Orexo’s extensive knowledge in sublingual technologies. Zubsolv is intended for maintenance treatment of people suffering from opioid dependence. Through application of its proprietary technologies Orexo has increased the bioavailability of the active ingredient, accelerated dissolve time, reduced tablet size and improved taste resulting in a preference of Zubsolv in comparison with Suboxone tablet. Zubsolv has the potential to be the first new entrant into a growing USD 1.5 billion market, with more than five million patients suffering from opioid dependence and where a majority of patients are not adequately treated today. Market potential for Zubsolv is at peak estimated at above USD 500 million in sales annually.

About Orexo
Orexo AB is an emerging specialty pharma company developing improved treatments using proprietary drug delivery technology. Orexo’s expertise is within the area of reformulation technologies and especially sublingual formulations. The company has a portfolio of revenue-generating US and EU approved products currently marketed under license and a pipeline of several reformulations of approved compounds for areas of unmet medical need. Orexo also has collaboration projects with several international pharma companies. Orexo AB, with its headquarters in Sweden, is listed on NASDAQ-OMX. The largest shareholders are Novo A/S and HealthCap.

For more information about Orexo please visit www.orexo.com.
Orexo is required under the Financial Instruments Trading Act to make the information in this press release public. The information was submitted for publication at 08:00 am CET on November 28, 2012.
This information was brought to you by Cision http://www.cisionwire.com

Contact:
Anders Lundström
President and CEO
Tel: +46 706-67 22 66
E-mail: anders.lundstrom@orexo.com
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Unread 05-26-2013, 06:14 PM   #6
JustinBe
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Default Zubsolv - The new Suboxone


Just like its competitor Suboxone, Zubsolv consists of a combination of buprenorphine and naloxone. The active ingredient, buprenorphine, has documented good efficacy in the treatment of opioid dependence. It eases withdrawal symptoms at the same time as it blocks the “high” effects of other opioids.


Combining buprenorphine and naloxone in a single tablet counteracts the “high” effect that may arise following inappropriate intravenous injection of a dissolved tablet. The risk of intravenous abuse is thereby reduced.


Through application of its proprietary technologies, Orexo has increased the bioavailability of the active ingredient, accelerated dissolve time, reduced tablet size and improved the taste.

Preference for Zubsolv has been compared with Suboxone® Tablet and Suboxone® Film in two independent studies. Key results from these two studies show that the subjects in the trials preferred Zubsolv over the competitors. Zubsolv preferred by 9 out of 10 participants in an acceptability study compared to the Suboxone® Film. Important parameters are improved taste, mouth-feel and ease of administration.


A New Drug Application for Zubsolv in the USA was submitted to the U.S. Food and Drug Administration, FDA, in September 2012. In November the FDA gave notice that the application had been accepted for review. The decision date has been set for July 6, 2013. The launch of Zubsolv is planned for September 2013.

Orexo:
"We will be compelled to launch Zubsolv at a lower price than the Suboxone-film."

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Unread 05-27-2013, 01:13 AM   #7
gotoffmdone
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"Opioid dependence is increasingly recognized as a major health problem in the US, with over two million Americans affected, costing the society an estimated USD 25 billion in related health care cost. The Zubsolv (OX219) treatment option will, once approved by the FDA, be directed towards the authorized specialized prescribers of Suboxone in US, of which 5000 physicians account for about 90% of all US prescriptions."


Is this about treating and epidemic or seeing a niche where money can be made. We all know that foe years there will be know generic and the cost will most lekely be comparable to all the other similar drugs on the market. Kinda like when you drive the interstae. It makes no difference where you stop to get gas, the stores on both the right and left side sem to always sale gas for the exact same price. The same gas may be cheaper up the road or down the road but at the same exit its odd how the prices are the same. I think the same will hold true with Bupe/naloxone. The initial statement in the above paragraph about opiate addiction being a major health concern in the U.S. is true in theory but often seen as a legal issue in practice. That major health concern is like anything else. People see a seat at the table when it comes to medication to treat it because the pie is so huge and "we" will pay whatever for a slice.

I sure hope more drug mfgs means more competetion which means less cost for the consumer but like the gas analogy I am skeptical that will be the case. As far as 8 out of 10 recommending one over the other that reminds me of the dentists who peddle this mouthwash or that mouthwash. Do enough studies and put in print the one most favorable to your point of view. That doesn't mean any of the studys are true or false, its about doing the experiment backwards and when you get the first result you are looking for stop and print that one.

I just wonder why people keep pouring their money into this medication if they do not stand to get a hefty return on their investment.

As far as the quote below:

http://www.addictionsurvivors.org/vb...cons/icon1.gif Zubsolv - The new Suboxone

Just like its competitor Suboxone, Zubsolv consists of a combination of buprenorphine and naloxone. The active ingredient, buprenorphine, has documented good efficacy in the treatment of opioid dependence. It eases withdrawal symptoms at the same time as it blocks the “high” effects of other opioids.


Combining buprenorphine and naloxone in a single tablet counteracts the “high” effect that may arise following inappropriate intravenous injection of a dissolved tablet. The risk of intravenous abuse is thereby reduced.


Through application of its proprietary technologies, Orexo has increased the bioavailability of the active ingredient, accelerated dissolve time, reduced tablet size and improved the taste.

Preference for Zubsolv has been compared with Suboxone® Tablet and Suboxone® Film in two independent studies. Key results from these two studies show that the subjects in the trials preferred Zubsolv over the competitors. Zubsolv preferred by 9 out of 10 participants in an acceptability study compared to the Suboxone® Film. Important parameters are improved taste, mouth-feel and ease of administration.


A New Drug Application for Zubsolv in the USA was submitted to the U.S. Food and Drug Administration, FDA, in September 2012. In November the FDA gave notice that the application had been accepted for review. The decision date has been set for July 6, 2013. The launch of Zubsolv is planned for September 2013.

Orexo:
"We will be compelled to launch Zubsolv at a lower price than the Suboxone-film."



"We will be compelled to launch Zubsolv at a lower price than the Suboxone-film."

First, that is not saying all that much and second, what is the compelling factor. It would have to be a com pelling drop in price to be felt in the pocket. I sure hope they are correct and send RB scurring about finding ways or the initiative the lower their cost. I personally like the film strips out of all I have taken. Naloxone or no naloxone it makes no difference to me.

I use the TEVA generic Texes and, in terms of cost, I save $2,280 per year just in medication cost.

I do not think any drug company that comes out with a drug containing Bupe/Naloxone and gets approval by the FDA to treat an opiate addiction that affects some 2,000,000 people in the U.S.(not counting their loved ones) costing the U.S. some $25,000,000,000 USD will not be "compelled" to offer the kind of savings I am presently getting in cost of medication. Of course not every Dr is willing to give the non Naloxone formulation.

Which brings me to the second question concerning a post above.

It says, "The Zubsolv (OX219) treatment option will, once approved by the FDA, be directed towards the authorized specialized prescribers of Suboxone in US, of which 5000 physicians account for about 90% of all US prescriptions."

Where is the other 10 percent scripts coming from and why not target them. Its is time to approve Bupe in all its forms for pain control and let Drs without that X factor kill two bird with ons stone. So many people are taking Bupe for no other reason than they became addicted to opioids due to chronic pain related issues which have not yet gone away and may never will.

I take Bupe for pain. I do so because I cannot seem to handle the quick increas in tolerance to regular pain medication. I hate the fact that my chart has to reflect the diagnosis of opiate addiction even if it is secondary to my chronic pain issues. A loot od us have problems that are well documented for which we could get pain medication. I have even thought of re-starting the use of Methadone but then i think about how my precip wds using Bupe would be for naught. It would be recognized for what we do today as opposed of what we done in years past. My PCP DR who does not give me Bupe but has methadone has not written in my chart anywhere where I had to go to detox or rehab. She wasn't invloved in any of it and she is of the opinion it is my business as to whether I put my business out there for everyone to see.

The hardest stain to get out of is red ink in a medical chart.

wayne
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Unread 06-17-2013, 08:09 AM   #8
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http://www.businesswire.com/news/hom...Study-Targeted

Orexo: First Patient Dosed in New Phase III Study Targeted towards a Future Clinical Indication Expansion for Zubsolv

UPPSALA, Sweden--(BUSINESS WIRE)--Regulatory News:

Orexo AB (STO:ORX) announces today that the first patient has been dosed with Zubsolv in a phase III study for a new clinical indication for Zubsolv.

Currently all buprenorphine/naloxone combination products licensed in the US are indicated for maintenance treatment only. Following review by the United States Food and Drug Administration (FDA), Orexo has initiated a phase III study, which once completed successfully, will be the basis for an application to expand the Zubsolv label with a clinical indication that encompass induction of treatment. Zubsolv is a novel sublingual formulation of buprenorphine and naloxone, with projected approval for use in maintenance treatment of opioid dependence by the FDA by July 2013.

Approximately 300 patients will be included in this US trial, and the study is expected to be completed in early 2014.

Induction of opioid dependence treatment is currently limited to buprenorphine products not containing naloxone. With a successful study result and subsequent regulatory approval, physicians will be able to prescribe Zubsolv on-label for induction of opioid addiction treatment, and thereby facilitate an easier transition onto such treatment regimen for patients addicted to opioids.

”Orexo is working with the FDA to secure an on-time approval of Zubsolv for use in maintenance treatment. Once approved Zubsolv will be directed to the more than five million US citizens suffering from opioid dependence. Our new clinical research program will ensure that Zubsolv gains an important clinical practice differentiation and will ensure that patients can be offered Zubsolv from when they commence treatment for their opioid addiction”, states Nikolaj Sørensen, President and Chief Executive Officer of Orexo.

He continued by adding “Orexo is committed to take a leading role in optimizing treatment of opioid dependence in the US. We have previously conducted acceptance trials for Zubsolv, in which 89% of trial participants favored Zubsolv over the conventional buprenorphine treatment modalities for opioid addiction, to understand how our formulation technology could aid in improving acceptability of buprenorphine treatment. The current clinical research initiative to expand the future labeled indication for use of Zubsolv is a logical next step, and we look forward to report on the data in the first half of 2014”

About the Induction Study

The study is conducted with approximately 300 patients in the US. It is a randomized, multi-center, blinded, parallel group, active-controlled non-inferiority study comparing Zubsolv with buprenorphine. It is expected to run until early 2014.

About Zubsolv

Zubsolv is a novel sublingual formulation of buprenorphine and naloxone using Orexo’s extensive knowledge in sublingual technologies. Zubsolv is intended for maintenance treatment of people suffering from opioid dependence. Through application of its proprietary technologies Orexo has increased the bioavailability of the active ingredient, accelerated dissolve time, reduced tablet size and improved taste. In a comparative acceptability study 9 out of 10 participants choose Zubsolv over the market leader Suboxone Film for a daily treatment. Zubsolv has the potential to be the first new entrant into a growing USD 1.5 billion market, with more than five million patients suffering from opioid dependence and where a majority of patients are not adequately treated today. Market potential for Zubsolv is at peak estimated at above USD 500 million in sales annually.

About Orexo

Orexo AB is an emerging specialty pharma company developing improved treatments using proprietary drug delivery technology. Orexo’s expertise is within the area of reformulation technologies and especially sublingual formulations. The company has a portfolio of revenue generating EU and US approved products currently marketed under licence and a pipeline of several reformulations of approved compounds for areas of unmet medical need. Orexo also has collaboration projects with several international pharma companies. Orexo AB, with its headquarters in Sweden, is listed on NASDAQ-OMX. The largest shareholders are Novo A/S and HealthCap.

For information about Orexo AB, please visit www.orexo.com

Orexo is required under the Financial Instruments Trading Act to make the information in this press release public. The information was submitted for publication at 08:45am CET on June 17th, 2013.


************************************************** *******


Here's a link to the clinical trial - it says it's not yet recruiting, but perhaps the site hasn't been updated yet.

http://clinicaltrials.gov/ct2/show/N...m=orexo&rank=3
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Unread 07-04-2013, 06:31 AM   #9
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http://www.bloomberg.com/news/2013-0...on-tablet.html

Orexo Wins U.S. Backing for Opioid-Addiction Tablet

Orexo AB (ORX), a Swedish specialty pharmaceutical company, won U.S. approval for a tablet to treat addiction to heroin and prescription painkillers.

The Food and Drug Administration cleared the drug known as Zubsolv for opioid dependence, the company said today in a statement. The tablet, which dissolves under the tongue, is the first competition to Reckitt Benckiser Group Plc (RB/)’s Suboxone.

Zubsolv combines buprenorphine and naloxone to ease withdrawal symptoms and block the high of opioids. Uppsala, Sweden-based Orexo, which specializes in reformulating drugs in sublingual form, estimates Zubsolv’s market potential to be at least $500 million in annual sales. The company generated about $48 million in revenue last year, according to data compiled by Bloomberg.

The FDA rejected a buprenorphine implant called Probuphine in April from Titan Pharmaceuticals Inc. (TTNP) The FDA asked for more data on the effect of higher doses of the medication and training for doctors on insertion and removal of the implant.

Buprenorphine and another treatment for opioid addiction, methadone, trick the brain into thinking it’s still getting opioids. Methadone users must be enrolled in a treatment program.

Prescription painkillers were involved in 14,800 overdose deaths in 2008, more than cocaine and heroin combined, the Centers for Disease Control and Prevention said. More than five million U.S. citizens suffer from opioid dependence, Orexo said.

Fighting Abuse

Drugmakers are attempting to make prescription opioids harder to abuse by creating tamper-resistant formulations that deter tablet crushing that gives addicts a greater high. The FDA determined in April that generic-pharmaceutical companies couldn’t make copies of closely held Purdue Pharma LP’s OxyContin that don’t have tamper resistant qualities.

Reckitt’s Suboxone was first approved as a tablet in 2002. The London-based company discontinued the tablets, and focused on film version, after it said in September 2012 it found significantly higher rates of accidental pediatric exposure with the tablets. The Suboxone film was approved in August 2010.

Zubsolv, like Suboxone, will be wrapped in individual child-resistant packages, Orexo said.

Orexo said July 1 that it formed a partnership with Publicis Touchpoint Solutions, based in Yardley, Pennsylvania, to help sell Zubsolv in the U.S..
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Unread 07-05-2013, 11:11 AM   #10
OutOfOurBoxes
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Default That's great news... Right??

Awesome...... That's very cool. I'm very happy that its finally here (or just about here)..

Nancy, so should we expect to see it available in pharmacies any time now? I mean do you think we could expect to see it as early as next week or do you think it will still take a couple months? I know you will let all of us know as soon as you do, but just your opinion, would it normally be available days after approval or is it normally a ways off even after approval? No matter what Thank you for that information..

I don't know what the prices for any of these new future meds might be once available, but I'm still looking forward to the competition in the market. It seems like when it comes to these types of medications that the market for them will be much "healthier" so to speak, because there will actually be some competition with this area of the market for a change (I hope)...

I'm happy to hear it no matter what happens in the market or anything else...

Thanks Nancy, Dre........
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Unread 07-06-2013, 07:34 AM   #11
NancyB
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Hi Dre, I emailed Orexo, but haven't heard back yet. The generic -tex and -one shipped immediately after FDA approval, so hopefully this will be the same. Any chance you could give your pharmacy a call and see what they have to say? I'll call some pharmacies around here (CT) and see if I can get some feedback also.

Nancy
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Unread 07-07-2013, 03:06 PM   #12
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Hi, I just received an email back from the president of Orexo in Sweden. I asked him about availability and pricing.

"...Regarding your questions, I have asked my staff in the US to reach out with more information. However, I can tell you we aim to launch the product in September on a national basis and we will have a medications assistance program in place at launch. We are still working on the final details regarding pricing, but we will inform you as we proceed."

This part is great news: ...we will have a medications assistance program in place at launch.

I'll post more information as I get it.

Nancy
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Unread 07-08-2013, 03:00 PM   #13
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Awesome, Thank you so much Nancy for posting this information... I did what you said and asked my pharmacist about it and they had no information on it and had no idea that this new medication was coming out (which didn't surprise me). That's another great thing about being apart off NNABT.ORG/ Addiction Survivors, is that we learn so much about the medications that we are taking and I feel like were always 10 steps ahead of the doctors and pharmacist when it comes to new future medications that have buprenorphine in them or new laws that affect our medication or treatment or how to get the most beneficial treatment when using these meds and the best ways to taper off these meds and also about side effects and how to reduce them or stop them all together and much more. I feel like many of us on this forum are more qualified to treat someone with this medication than many of the doctors are. Of course that's because we are on this forum and because we have people like You and Tim and everyone who has posted through the years who do all the research into buprenorphine..
Back on topic, anyway so I got all my questions answered, thank you. I'm so happy to hear about the medication assistance program, that's the best news... Thanks Nancy, I can't wait to hear more info as you get it... I hope you and everyone else has a great day/night...

Dre...
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Unread 07-11-2013, 06:41 AM   #14
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Default New, better version of Suboxone

FDA Approves Zubsolv™ for the Maintenance Treatment of Opioid Dependence

Uppsala, Sweden – July 4, 2013 – Orexo today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for Zubsolv™ (buprenorphine/naloxone) sublingual tablet CIII. Zubsolv is indicated for use as maintenance treatment for people suffering from opioid dependence and should be used as part of a complete treatment plan to include counselling and psychosocial support. Zubsolv is a once-daily, sublingual tablet with an advanced formulation of buprenorphine and naloxone that fully dissolves within minutes. Compared with other buprenorphine/naloxone treatments, Zubsolv has higher bioavailability, faster dissolve time, and smaller tablet size with a new menthol taste. Zubsolv will be launched in September by our subsidiary in the United States, Orexo US, Inc and our partner Publicis Touchpoint Solutions.
Opioid dependence affects nearly 5 million people across the United States. Although it is a treatable condition only 20 percent of Americans suffering from opioid dependence receive treatment today. Orexo provides with Zubsolv an additional treatment choice with new unique product features that may be important for attracting and retaining more patients in treatment for opioid dependence.
“Orexo has developed Zubsolv as a novel sublingual therapy meeting the needs of millions of patients that suffers from opioid dependence to offer them a new choice of treatment. Zubsolv has in previous studies showed a high acceptability compared to the leading treatment modalities in the market. We expect Zubsolv will be well received by patients and prescribers and we anticipate a peak market potential of at least $500M,” said Nikolaj Sørensen, President and CEO of Orexo AB.
He continued adding “The approval of Zubsolv, which is based on our advanced formulation capabilities and developed using our proprietary technology, is a great tribute to the world class pharmaceutical formulation team at Orexo. Today is a proud day for Orexo with the third product approved in the US coming out of our R&D department in Uppsala.”
Opioid dependence greatly impacts the U.S. economy, with about $56 billion spent on the disease per year. In addition, the average healthcare cost per patient with opioid dependence is eight times higher compared to nondependent patients. There is also a great impact on human life, with almost 17,000 deaths from opioid pain relievers in the U.S. every year.
“In addiction medicine, the recovery process can be challenging. Products designed to meet patient preferences have the potential to more successfully support their recovery," said Louis E. Baxter, Sr., MD, FASAM, past president of the American Society of Addiction Medicine. "The approval of Zubsolv provides a new treatment option that offers unique advantages specifically designed to meet the unmet needs expressed by patients and has the potential to improve patient adherence, thereby reducing relapse rates and improving successful patient outcomes.”
Orexo’s proprietary technology relating to Zubsolv is protected by patents and patent applications in the US and other markets worldwide. Projected expiry dates for this IP range from 2019 to 2032.
For further information, please contact:
Nikolaj Sørensen, President and CEO, Orexo AB
Tel: +46 70-350 78 88, E-mail: nikolaj.sorensen@orexo.com
About Orexo AB
Orexo is an emerging specialty pharma company with commercial operations in the United States and R&D in Sweden developing improved treatments using proprietary drug delivery technology. Orexo’s expertise is within the area of reformulation technologies and especially sublingual formulations. The company has a portfolio of revenue-generating US and EU approved products currently marketed under license and a pipeline of several reformulations of approved compounds for areas of unmet medical need. Orexo also has collaboration projects with several international pharmaceutical companies. Orexo, with its headquarters in Sweden, is listed on NASDAQ-OMX. The largest shareholders are Novo A/S and HealthCap.
For more information about Orexo please visit www.orexo.com.
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Unread 08-07-2013, 07:15 AM   #15
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http://www.orexo.com/en/Investor-Rel...s/?guid=795790

Orexo: First patient dosed in new study on long-term adherence to treatment of opioid dependence with Zubsolv

Uppsala, Sweden – August 7, 2013 – Orexo AB announces that the first patient has been dosed in a new clinical study (ISTART; Induction, STabilization, Adherence, Retention Trial), designed to determine early treatment-efficacy and treatment-adherence to Zubsolv® (buprenorphine and naloxone) sublingual tablets in comparison to conventional buprenorphine/naloxone for the maintenance treatment of opioid dependence.

During 2012 Orexo completed an acceptability study, in which 89% of study participants, all healthy volunteers, favored Zubsolv over Suboxone® Film. The ISTART study is a natural next step in which the benefit of Zubsolv on retention, stabilization and adherence to treatment will be determined in opioid dependent patients.

The primary endpoint of the new ISTART study is retention in treatment at day fifteen following initiation of opioid replacement therapy. Treatment adherence is particularly important in the initial phases of addiction therapy, and prior research indicates that many patients do not tolerate or accept the previously used treatment modalities. Patients in the ISTART study will, after day 15, be followed in an extended observation period to explore long-term adherence to Zubsolv and collect clinical outcome data. The multi-center ISTART study will enroll more than 700 patients in the United States, and is one of the largest clinical trials undertaken in this field.

“Lack of adherence to the prescribed treatment of opioid dependence is a major issue, resulting in high level of personal suffering and expense for those affected. We know that many patients find characteristics of the existing treatment modalities to be an obstacle, and that this contributes to the drop-out rates from treatment previously observed. With Zubsolv we have developed an advanced sublingual tablet that addresses these obstacles through fast dissolve time, new menthol taste and small easy to administer tablet size”, say Stuart Gitlow, President of the American Society of Addiction Medicine and consultant to Orexo.

Nikolaj Sørensen, President and Chief Executive Officer of Orexo AB commented “ISTART is the third major study focused on treatment optimization within opioid dependence that Orexo is funding. These programs are undertaken to contribute further insights to how opioid replacement therapy may improve the lives of millions of patients suffering from opioid dependence in United States. Our research shows that the Zubsolv product features such as dissolve time and improved taste are important determinants for acceptability of sublingual treatments, and we look forward to expand this evidence base into treatment of opioid dependence through completion of the ongoing studies.”

For further information, please contact:
Nikolaj Sørensen, President and CEO of Orexo AB
Tel: + 46-703 50 78 88

About the Study
The ISTART clinical study is expected to enrol approximately 700 patients in the US. It is a randomized, multi-center, non-inferiority study comparing Zubsolv® with Suboxone Film. Each enrolled patient will participate for 36 days and after completing this study the patients are invited to a follow-up study running for 24 weeks.

About Zubsolv®
Zubsolv (buprenorphine and naloxone) sublingual tablet CIII is approved by the U.S. Food and Drug Administration (FDA) as maintenance treatment for people suffering from opioid dependence. Zubsolv should be used as part of a comprehensive treatment plan which includes counselling and psychosocial support. Zubsolv is a novel sublingual formulation of buprenorphine and naloxone using Orexo’s extensive knowledge in sublingual technologies. Through application of its proprietary technologies Orexo has increased the bioavailability of the active ingredient, accelerated dissolve time, reduced tablet size and improved taste. In a comparative acceptability study 9 out of 10 participants choose Zubsolv over the market leader Suboxone Film for a daily treatment. Zubsolv has the potential to be the first new entrant into a growing USD 1.5 billion market, with more than five million patients suffering from opioid dependence and where a majority of patients are not adequately treated today. Market potential for Zubsolv is at peak estimated at above USD 500 million in sales annually.

Orexo’s proprietary technology relating to Zubsolv is protected by patents and patent applications in the US and other markets worldwide. Projected expiry dates for this IP range from 2019 to 2032.

About Orexo
Orexo AB is an emerging specialty pharma company developing improved treatments using proprietary drug delivery technology. Orexo’s expertise is within the area of reformulation technologies and especially sublingual formulations. The company has a portfolio of revenue generating EU and US approved products currently marketed under licence and a pipeline of several reformulations of approved compounds for areas of unmet medical need. Orexo also has collaboration projects with several international pharma companies. Orexo AB, with its headquarters in Sweden, is listed on NASDAQ-OMX. The largest shareholders are Novo A/S and HealthCap.

For information about Orexo AB, please visit www.orexo.com.

Orexo is required under the Financial Instruments Trading Act to make the information in this press release public. The information was submitted for publication at 08:15 am CET on August 7, 2013.
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Unread 08-09-2013, 08:29 PM   #16
asouth32
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What bothers me about a new medication is when they say that they will offer a medication assistance program at launch. To me I hear that and I think this is not going to be any cheaper of notice, kind of like when Generic Suboxone tablets started surfacing in the pharmacies. Yeah assistance programs are nice, but what irks me is my husbands BP medication doesn't have an assistance program and yet he needs that just like I need my medicine. My mother's heart medication is on the 4 dollar list and I would just about bet that there is as many heart patients as there is addiction patients. It is the same thing with gas prices, if they dropped the prices down people would actually travel more and they would make their money back in the losses of dropping the initial price. When gas prices was 89 cents a gallon which was the year I graduated HS, we used to get out and go cruising around town.
I know as well as you guys know if they dropped the price of the medication down even by half, the amount of patients would double to get off Opiates. They would make thier money back, but this is the problem with the world today. The fat cats aren't sympathetic to how much people have to pay for their medication as long as they are paying for it. Too much greed in the world these days.
Anyways, back to the Zubsolv I dont know if I would switch because I dont take a full 8mg a day. I might take half a dose or closer to 6mg and from what I read it comes in 8mg/2mg doses? I prefer having my strips but now if it comes out and the price is half of the films, then I will switch over to save us more money. My doctor being the caring person that he is allows me to come in whenever my script runs out unless I need something in between those times. He knew that we were trying to get financially stable and wanted to help us out some. I thank him everytime for that. I mean EVERY time that I see him for that, most doctors would want their monthly every month. My doctor in Danville, you was not allowed to miss one appointment, if your arm fell off and was in the hospital you better drag your ass to the doctor's office. I had the flu along with my husband and my mother who at the time was my only source of transportation, I called to try and reschedule and they said if I did I would be kicked out.
At the time though, I couldn't really afford to switch doctors. My husband being the wonderful man that he is has allowed me to do that. He hates the drive to Lexington but he is glad that I have found a doctor that I like and that makes me happy.
I didnt mean to ramble on, I apologize. I just dont see that this medication is going to be much cheaper than the brand name Suboxone or the generic version at this time. I hope that they prove me wrong.
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Unread 09-05-2013, 11:40 AM   #17
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(I've bolded some salient points. -Nancy)

Orexo: Orexo provides update on reimbursement and launch preparations for Zubsolv

http://www.swedishwire.com/press-rel...ns-for-zubsolv

Uppsala, Sweden - September 5, 2013 - Orexo announced today that the preparations for launch of Zubsolv® (buprenorphine and naloxone) sublingual tablets (CIII) has progressed according to plans and that Zubsolv will be available in pharmacies across the U.S. from September 16. Zubsolv received approval from the U.S. Food and Drug Administration (FDA) in July 2013 for the maintenance treatment of opioid dependence, as part of a complete treatment plan including counseling and psychosocial support.

Market access continues to be a key focus area for Orexo and negotiations with payers are progressing as anticipated. Zubsolv will at launch be reimbursed in more than 70% of the current market for opioid replacement therapy. Zubsolv will be launched with list-pricing comparable to Suboxone film, but with an enhanced patient assistance through co-pay support initiatives. Interest in Zubsolv among the largest commercial plans is strong. For instance, a rebate agreement is signed with CVS Caremark which allows its commercial PBM clients to qualify for rebates if the client places Zubsolv in a preferred formulary position. Earlier this year CVS Caremark announced that effective January 1st 2014, Suboxone Film has been removed from the formularies for its commercial clients who participate in the formulary drug exclusion program. For those clients, Zubsolv will be the only single source brand drug covered. Orexo plans to provide further updates on developments in the US reimbursement landscape for Zubsolv in relation to the quarterly earnings releases.

Orexo has during the past 8 weeks finalized the establishment of the commercial infrastructure for launch of Zubsolv in the United States. The supply chain has inventory to meet market demands, and Zubsolv tablets will at launch be available through all leading wholesalers and in more than 11.000 pharmacies. Zubsolv is exclusively being supplied in specially designed child-resistant packages, in which the individual tablets are wrapped in a special blister foil that optimally protect children against accidental exposure. Zubsolv will at launch be the only buprenorphine containing product, which is commercialized with the highest degree of child resistant packaging protection (F1-grade).

The previously announced US commercial partnership with Publicis Touchpoint Solutions is fully operational and the commercial organization has been staffed with highly competent and talented people. The sales teams have been operational in the most important districts since early August and the sales representatives have engaged with many key prescribers prior to launch of Zubsolv. The prescribers recognize the need for access to additional choices of treatment, and the feedback obtained indicates a high unprompted awareness of both Zubsolv and Orexo. To their support, Orexo has launched a patient support program (www.rise-us.com), a Zubsolv home page (www.zubsolv.com) and a toll free number 1-888-ZUBSOLV, all developed for the US market.

"We are now entering the most exciting time in the history of Orexo. Having worked closely with my team in the US and our partner Publicis Touchpoint Solutions during the summer, I am confident we are headed for a successful launch. Based on our recent study, in which 9 out of 10 participants preferred Zubsolv versus the market leader, the strong feedback from prescribers who explicitly demand alternatives for patients, and our improving market access position, my confidence in that sales of Zubsolv can exceed $500M within 3 years after launch has been strengthened. I am pleased with the progress in market access achieved since approval of Zubsolv, and remain certain that we will have a comprehensive and competitive market access position by the end year of this across commercial and public payer segments" said Nikolaj Sørensen, President and CEO.

As a result of the positive response in the US and growing interest in Orexo, a process has been initiated to improve access for US investors to trade in the Orexo share by establishment of a sponsored level 1 American Depositary Receipt (ADR) program. Further details pertaining to this will be provided at a later stage.

For further information, please contact:
Nikolaj Sørensen, President and CEO
Tel: + 46-703 50 78 88, E-mail: nikolaj.sorensen@orexo.com

About Zubsolv
Zubsolv® (buprenorphine and naloxone) sublingual tablet (CIII) is indicated for the maintenance treatment of opioid dependence and should be used as part of a comprehensive treatment plan, which includes counseling and psychosocial support. Treatment should be initiated under the direction of physicians who are certified under the Drug Addiction Treatment Act of 2000, and who have been assigned a unique identification number ("X" number).

Zubsolv sublingual tablets deliver more buprenorphine to the bloodstream, allowing patients to use a lower dose and thereby reducing the amount of available drug for potential misuse and diversion. The naloxone component of Zubsolv further reduces the potential for IV misuse and diversion.

Zubsolv sublingual tablet can be abused in a manner similar to other opioids, legal or illicit. Clinical monitoring appropriate to the patient's level of stability is essential. Liver function should be monitored before and during treatment. Children who take Zubsolv sublingual tablet can have severe, possibly fatal, respiratory depression. Emergency medical care is critical. Keep Zubsolv sublingual tablet out of the sight and reach of children. Zubsolv will be the only opioid dependence treatment that is available in the highest level of child resistant unit dose F1 packaging, thereby further reducing the chance of unintended pediatric exposure.

Adverse events commonly observed with the sublingual administration of buprenorphine/naloxone sublingual tablets during clinical trials and post-marketing experience are headache, nausea, vomiting, hyperhidrosis, constipation, signs and symptoms of withdrawal, insomnia, pain and peripheral edema.

The proprietary technology relating to Zubsolv is protected by patents and patent applications in the U.S. and other markets worldwide. Projected expiry dates for this IP range from 2019 to 2032.

For information about Zubsolv, please visit www.zubsolv.com

About Orexo AB
Orexo AB is an emerging specialty pharma company with commercial operations in the United States and R&D in Sweden developing improved treatments using proprietary drug delivery technology and commercial operations in the United States. The company is commercializing its proprietary product, Zubsolv® (buprenorphine and naloxone), for maintenance treatment of opioid dependence, in the United States. Zubsolv is a novel sublingual formulation of buprenorphine and naloxone using Orexo's extensive knowledge in sublingual technologies. Orexo has a portfolio of two approved and revenue generating products currently marketed under license in the EU and US. Orexo's development expertise is within the area of reformulation technologies and especially sublingual formulations. Orexo AB, with its headquarters in Sweden, is listed on NASDAQ-OMX. The largest shareholders are Novo A/S and HealthCap.

For information about Orexo AB, please visit www.orexo.com.

Zubsolv is a new, advanced formulation of buprenorphine and naloxone, approved for maintenance treatment of opioid dependent patients, which provides fast dissolve time, small tablet size, a new menthol flavor and a higher bioavailability than current marketed products.

Orexo is required under the Financial Instruments Trading Act to make the information in this press release public. The information was submitted for publication at 09:30 am CET on September 5, 2013.
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Unread 09-05-2013, 11:45 AM   #18
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Just went to http://www.zubsolv.com and here's the patient assistance/co-pay link:
http://www.zubsolv.com/about-zubsolv...nt-savings.php

"If you’re eligible, this copay card for ZUBSOLV can help lower your out-of-pocket costs like copayments, coinsurance, or deductibles on your prescription for ZUBSOLV. The copay card for ZUBSOLV covers up to $75 of your prescription costs

Call toll free 1-888-ZUBSOLV (1-888-982-7658) to see if you are eligible for a copay card for ZUBSOLV"

Nancy
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Unread 09-05-2013, 09:42 PM   #19
asouth32
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As soon as someone gets this filled, I would like to know how it is. Which I am sure that we all want to know if it works the same, if there is a difference in how you feel etc. I tried to find on the site if it is able to be broken up because some of us take our doses throughout the day instead of all at once. I am not just taking it for cravings but for pain that I am dealing with in my back. I find that the Suboxone helps me wonders with my back and other pains as well. I see that it is not insanely cheaper than Suboxone even with the coupon from looking on Goodrx.com I just wonder when it will be available at the pharmacies because I am sure that its not at mine yet. However, the prices are showing up for Walmart and some others.
I got a price for the 1.4mg at 116 for 30 tablets and for the 5.7mg tablets a little over 220 bucks. So, take the 75 bucks off of that and it comes to 145 for 30 tablets. I pay 8 bucks a piece for the strips and at 30 a month which is 240. The 50 dollar coupon from RB knocks that down to 190 a month. That is a 45 buck savings, not insanely better but it is better. I guess we all have our hopes high thinking that it will be as cheap as Subutex or I did anyways. Nothing wrong with hoping. It is a wonderful thing however that it is not supporting RB.
That alone makes it better, I just wish that it was cheaper for the ones who have no insurance or pay enormous amounts for their doctor's visits. I don't have insurance but my doctor is allowing me to come in only when I run out of medication which helps alot.
This is an improvement.
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Unread 09-16-2013, 10:23 AM   #20
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http://www.marketwatch.com/story/zub...nce-2013-09-16

PRESS RELEASE

Zubsolv® Now Available in the U.S. for the Maintenance Treatment of Opioid Dependence

Zubsolv is a new, advanced formulation treatment option for opioid dependent patients that provides higher bioavailability, fast dissolve time, smaller tablet size and a new menthol flavor


NEW YORK, Sept. 16, 2013 /PRNewswire via COMTEX/ -- Orexo U.S. announced today that Zubsolv (buprenorphine and naloxone) sublingual tablets (CIII) are commercially available in pharmacies across the United States. In July 2013, Zubsolv received approval from the U.S. Food and Drug Administration (FDA) for the maintenance treatment of opioid dependence. Zubsolv should be used as part of a complete treatment plan, including counseling and psychosocial support.

The most effective treatment for opioid dependence is a combination of pharmacological therapy and psychological counseling.[i],[ii] Opioid dependence is a disease, like hypertension, schizophrenia or diabetes, and affects nearly 5 million people across the United States.[iii],[iv],[v] Although it is a treatable condition, even among those diagnosed as opioid dependent, 60% do not receive treatment.[iii] Every year thousands of patients continue to misuse opioids rather than risk the stigma of public exposure by receiving treatment.[vi]

The higher bioavailability of Zubsolv allows for a lower dose of buprenorphine being administered which, in combination with the naloxone component, reduces the amount of available drug and the likelihood of potential misuse and diversion. Zubsolv is the only opioid dependence treatment available today in the highest level of child resistant packaging (F1), and each Zubsolv tablet is supplied in individual unit-dose blister packages, reducing the chance of unintended pediatric exposure

"Orexo is committed to advance the treatment for patients suffering from opioid dependence. Zubsolv was specifically designed to address many of the unmet needs expressed by patients being treated for opioid dependence," said Robert DeLuca, R.Ph., President, Orexo U.S. "In an open-label, crossover study in 28 subjects, we found that ninety-six percent preferred the menthol taste of Zubsolv over the most commonly prescribed formulation of buprenorphine/naloxone."

In addition to the commercial launch of Zubsolv, Orexo issued today the Time and Taste Challenge, inviting patients and prescribers to register to receive demonstration placebo tablets to experience the taste and dissolve time for this new advanced formulation. The placebo tablets are for demonstration purposes only and do not contain active medication. Register for the Time and Taste Challenge at www.zubsolv.com or by calling 1-888-ZUBSOLV.

Orexo is also premiering RISE(TM), a 24/7, real-time, customizable support program informed by patients in recovery. The HIPPA compliant program provides information about opioid dependence and resources to help facilitate a two-way conversation between patients and their chosen mentor network which may also include their doctor and counselor. The program is mobile enabled, allowing for access anytime, anywhere. Visit www.rise-us.com to learn more about the RISE program.

Opioid dependence greatly impacts the U.S. economy, with about $56 billion spent on the disease per year.[vii] In addition, the average healthcare cost per patient with opioid dependence is eight times higher compared to nondependent patients.[viii] There also is a great impact on human life, with almost 17,000 deaths from opioid pain relievers in the U.S. every year.[ix]

Orexo also announced today that it has established a sponsored level 1 American Depositary Receipt (ADR) program in the United States. Orexo's ADR program trades in the US over-the-counter (OTC) market, under the symbol ORXOY, with each ADR comprised of 1 ordinary share. Orexo's ordinary shares are listed on the NASDAQ OMX Stockholm Exchange under the symbol ORX.

For further information contact: Robert DeLuca, President, Orexo U.S., Inc. Telephone: 1-973-993-4866

About Opioid Dependence Opioid dependence is a chronic relapsing disorder like diabetes or high blood pressure, and can develop as a result of either legitimate use or misuse of opioids. Frequent opioid use physically changes the brain, so that the brain starts to think that it needs opioids to function normally. Subsequently, people with opioid dependence experience cravings and symptoms of withdrawal when the effects of opioids begin to wear off.

About Zubsolv Zubsolv® (buprenorphine and naloxone) sublingual tablet (CIII) is indicated for the maintenance treatment of opioid dependence and should be used as part of a comprehensive treatment plan, which includes counseling and psychosocial support. Treatment should be initiated under the direction of physicians who are certified under the Drug Addiction Treatment Act of 2000, and who have been assigned a unique identification number ("X" number).

Zubsolv sublingual tablet can be abused in a manner similar to other opioids, legal or illicit. Clinical monitoring appropriate to the patient's level of stability is essential. Liver function should be monitored before and during treatment.

Children who take Zubsolv sublingual tablet can have severe, possibly fatal, respiratory depression. Emergency medical care is critical. Zubsolv is the only opioid dependence treatment that is available in the highest level (F1) child resistant, individual unit-dose packaging, thereby reducing the chance of unintended pediatric exposure. Keep Zubsolv sublingual tablets out of the sight and reach of children.

Adverse events commonly observed with the sublingual administration of buprenorphine/naloxone sublingual tablets during clinical trials and post-marketing experience are headache, nausea, vomiting, hyperhidrosis, constipation, signs and symptoms of withdrawal, insomnia, pain and peripheral edema.

About Orexo U.S., Inc. Orexo U.S., Inc. is an emerging specialty pharmaceutical company marketing improved treatments for opioid dependence using proprietary drug delivery technology. To receive more information please contact Orexo at 1-888-Zubsolv.

About Orexo AB Orexo AB is an emerging specialty pharma company with commercial operations in the United States and R&D in Sweden developing improved treatments using proprietary drug delivery technology. Orexo's expertise is within the area of reformulation technologies and especially sublingual formulations. The company has a portfolio of revenue-generating U.S. and EU approved products currently marketed under license and a pipeline of several reformulations of approved compounds for areas of unmet medical need. Orexo also has collaboration projects with several international pharmaceutical companies. Orexo AB, with its headquarters in Sweden, is listed on NASDAQ-OMX. The largest shareholders are Novo A/S and HealthCap.

Orexo's proprietary technology relating to Zubsolv is protected by patents and patent applications in the U.S. and other markets worldwide. Projected expiry dates for this IP range from 2019 to 2032.

_______________________________
[i] American Family Physician. "Buprenorphine: Effective Treatment of Opioid Addiction Starts in the Office." May 2006.
[ii] National Institute on Drug Abuse. "Principles of Drug Addiction Treatment: A Research-Based Guide (Third Edition)." December 2012.
[iii] Science & Practice Perspectives. "The Neurobiology of Opioid Dependence: Implications for Treatment." July 2002.
[iv] Cleveland Clinic Journal of Medicine. "Buprenorphine maintenance: A new treatment for opioid dependence." July 2007.
[v] Substance Abuse and Mental Health Services Administration, Results from the 2010 National Survey on Drug Use and Health: Summary of National Findings,
NSDUH Series H-41, HHS Publication No. (SMA) 11-4658. Rockville, MD: Substance Abuse and Mental Health Services Administration, 2011.
[vi] Journal of Managed Care Pharmacy. "Empirical view of Opioid Dependence." February 2010.
[vii] Pain Medicine. "Societal Costs of Prescription Opioid Abuse, Dependence, and Misuse in the United States." April 2011.
[viii] Journal of Managed Care Pharmacy. "Direct Costs of Opioid Abuse in an Insured Population in the United States." July/August 2005.
[ix] Centers for Disease Control and Prevention. Prescription Painkiller Overdoses. Accessed July 3, 2013. http://www.cdc.gov/VitalSigns/pdf/20...vitalsigns.pdf.



SOURCE Orexo U.S.

Copyright (C) 2013 PR Newswire. All rights reserved
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Unread 09-18-2013, 08:25 AM   #21
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http://www.chaindrugreview.com/front...-to-pharmacies

Orexo rolls out Zubsolv to pharmacies

NEW YORK – Providing another option for people addicted to painkillers, Orexo U.S. Inc. has released Zubsolv sublingual tablets to U.S. pharmacies.

The company said Monday that the launch of Zubsolv (buprenorphine and naloxone, CIII) follows Food and Drug Administration approval of the medication, which dissolves under the tongue, in July.

Indicated for the maintenance treatment of opioid dependence, Zubsolv is intended to be used as part of a comprehensive treatment plan that includes counseling and psychosocial support.

Orexo pointed out that the higher bioavailability of Zubsolv enables the administration of a lower dose of buprenorphine, which in combination with the naloxone component reduces the amount of available drug as well as the likelihood of potential misuse and diversion.
In addition, the company said, Zubsolv is the only opioid dependence treatment available today in the highest level of child-resistant packaging (F1). Each Zubsolv tablet comes in individual unit-dose blister packages.

"Orexo is committed to advance the treatment for patients suffering from opioid dependence. Zubsolv was specifically designed to address many of the unmet needs expressed by patients being treated for opioid dependence," stated Robert DeLuca, president of Orexo U.S. "In an open-label, crossover study in 28 subjects, we found that 96% preferred the menthol taste of Zubsolv over the most commonly prescribed formulation of buprenorphine/naloxone."

Along with the commercial launch of Zubsolv, Orexo has kicked off the Time and Taste Challenge, inviting patients and prescribers to register to receive demonstration placebo tablets to experience the taste and dissolve time for the new advanced formulation of the medication.

Orexo also has introduced RISE, a 24/7, real-time, customizable support program for patients in recovery. The HIPPA-compliant program provides information about opioid dependence and resources to foster interaction between patients and their mentor network, which may also include their doctor and counselor. The program is mobile-enabled, allowing for anytime, anywhere access.

A chronic relapsing disorder that can develop from legitimate use or misuse of controlled substances, opioid dependence takes a big toll on the U.S. economy, with about $56 billion spent on the condition per year, according to a study cited by Orexo. The average health care cost per opioid-dependent patient is eight times higher. Almost 17,000 people die from opioid pain relievers in the United States each year.
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Unread 09-19-2013, 08:17 AM   #22
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Any info on price yet? as in, comparison to Suboxone film?
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Unread 09-19-2013, 02:54 PM   #23
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I did a price check on Goodrx.com and it says in my area which is Central KY, 30 of the 5.7mg tablets cost 220.00 which is the same price as the strips. However, they have a 75 dollar coupon instead of the 50 dollar coupon that Suboxone has. I don't know if there is a certain amount that you can get to use the coupon like Suboxone has the 14 minimum that you can fill before you can use the coupon. That is at Walmart/CVS those prices that I found in my area. Now I haven't called and actually spoken to anyone at a pharmacy yet. You are supposed to be able to use the Good RX coupons at any of the places that are listed, but I have not had any luck when I went to Walgreen's and tried to get some strips filled. I asked my pharmacy but they haven't been able to find out anything just yet.
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Unread 10-04-2013, 02:46 PM   #24
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Anyone have experiences with it yet? Am wondering if there are any benefits to it, since the film is just fine for me. I've gotten used to the awful taste and after-taste. I wonder why the tests show so many people prefer it over the film. WHY? Bc of the taste? Or the bioavailability, how much more than film to inspire a switch? Otherwise, sure, I guess so, I think it comes down to whatever my out-of-pocket is.

Last time I picked up my script, I got it for free after my doc calling in for preauthorization to my insurance and using the coupon. Plus she wrote me a script for 16mgs/day and I only take 8 now, so I don't have to pay for another expensive doc appt for awhile, which is not covered by my insurance as much $ bc she's not in-network. But compared to my experience w Sadodoc, she's oh so worth it! I missed my last appt on Wednesday which was on the same day I got my molar removed and didn't realize it until that morning...she hasn't called me back. Sigh. It's so hard to keep these docs if u miss an appt accidentally.

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Unread 10-04-2013, 03:40 PM   #25
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Hi SubGirl007, Dre responded about his experience in this thread:
http://www.addictionsurvivors.org/vb...ad.php?t=28968

Hopefully everything will be ok with your doctor. You might want to call again Monday - in case she didn't get the message?

Nancy
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Unread 10-13-2013, 02:01 PM   #26
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Quote:
Originally Posted by SubGirl007 View Post
Anyone have experiences with it yet? Am wondering if there are any benefits to it, since the film is just fine for me. I've gotten used to the awful taste and after-taste. I wonder why the tests show so many people prefer it over the film. WHY? Bc of the taste? Or the bioavailability, how much more than film to inspire a switch? Otherwise, sure, I guess so, I think it comes down to whatever my out-of-pocket is.

Last time I picked up my script, I got it for free after my doc calling in for preauthorization to my insurance and using the coupon. Plus she wrote me a script for 16mgs/day and I only take 8 now, so I don't have to pay for another expensive doc appt for awhile, which is not covered by my insurance as much $ bc she's not in-network. But compared to my experience w Sadodoc, she's oh so worth it! I missed my last appt on Wednesday which was on the same day I got my molar removed and didn't realize it until that morning...she hasn't called me back. Sigh. It's so hard to keep these docs if u miss an appt accidentally.

L .
I hope I am doing this right, as I am new to message boards and forums...

Anyway, on topic, I just switched to zubsol 3 days ago and will share how it has been for me thus far. I used the coupon my doctor gave me, which can be used twice a month. Of my prescription, I filled 12 tabs at 5.7mg (equal to 8mg suboxone) for about $25. This is a decent savings from what I was paying for the suboxone film with coupon. The pill itself is better in that it is smaller, devolves better, and has less of an aftertaste. The bioavailability of zubsolv also seems to be noticeably better, which brings up a concern...tapering. I had decided it was time to taper from the film, an easier decision to adhere to when you don't really feel the effects of your medication. But the new zubsolv worked for me the way the suboxone tabs did the first couple days I took it, giving me that slight euphoric feeling and a nudge (motivation). But perhaps this too will only be the initial reaction, lasting just a couple/few days, and instead will do a better job of allowing me to go longer between doses. It's going to be somewhat more challenging to cut the dose down, as this pill is small and not perforated, but will figure that out since it is far superior to the film in every other way.
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Unread 10-24-2013, 05:49 PM   #27
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Default Zubsolv now available

Hi, Darladawn. I’m glad to hear that Zubsolv is working for you so far. Because ZUBSOLV (buprenorphine and naloxone) sublingual tablet (CIII) delivers more active ingredient to the bloodstream, it allows patients to use a lower strength – this reduces the amount of available drug for potential misuse and diversion. An effective treatment approach for opioid dependence is a comprehensive one that includes pharmacological therapy, counseling, and psychosocial support. When tapering, continue to work closely with your doctor.

ZUBSOLV is indicated for the maintenance treatment of opioid dependence and should be used as part of a complete treatment plan that includes counseling and psychosocial support.
ZUBSOLV is a controlled substance (CIII) because it contains buprenorphine, which can be a target for people who abuse prescription medicines or street drugs. Keep your ZUBSOLV in a safe place to protect it from theft. Never give your ZUBSOLV to anyone else; it can cause death or harm them. Selling or giving away this medicine is against the law.

ZUBSOLV contains an opioid that can cause physical dependence. Do not stop taking ZUBSOLV without talking to your doctor. You could become sick with uncomfortable withdrawal signs and symptoms because your body has become used to this medicine. Physical dependence is not the same as drug addiction. ZUBSOLV is not for occasional or “as needed” use.

Do not inject ("shoot-up") ZUBSOLV. Injecting ZUBSOLV may cause life-threatening infections and other serious health problems. Injecting ZUBSOLV may cause serious withdrawal symptoms such as pain, cramps, vomiting, diarrhea, anxiety, sleep problems, and cravings.

Note: I am compensated by Orexo to provide expertise and for my time to post.
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Unread 10-24-2013, 06:49 PM   #28
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Quote:
Originally Posted by addiction.scholar View Post
Hi, Darladawn. I’m glad to hear that Zubsolv is working for you so far. Because ZUBSOLV (buprenorphine and naloxone) sublingual tablet (CIII) delivers more active ingredient to the bloodstream, it allows patients to use a lower strength – this reduces the amount of available drug for potential misuse and diversion. An effective treatment approach for opioid dependence is a comprehensive one that includes pharmacological therapy, counseling, and psychosocial support. When tapering, continue to work closely with your doctor.

ZUBSOLV is indicated for the maintenance treatment of opioid dependence and should be used as part of a complete treatment plan that includes counseling and psychosocial support.
ZUBSOLV is a controlled substance (CIII) because it contains buprenorphine, which can be a target for people who abuse prescription medicines or street drugs. Keep your ZUBSOLV in a safe place to protect it from theft. Never give your ZUBSOLV to anyone else; it can cause death or harm them. Selling or giving away this medicine is against the law.

ZUBSOLV contains an opioid that can cause physical dependence. Do not stop taking ZUBSOLV without talking to your doctor. You could become sick with uncomfortable withdrawal signs and symptoms because your body has become used to this medicine. Physical dependence is not the same as drug addiction. ZUBSOLV is not for occasional or “as needed” use.

Do not inject ("shoot-up") ZUBSOLV. Injecting ZUBSOLV may cause life-threatening infections and other serious health problems. Injecting ZUBSOLV may cause serious withdrawal symptoms such as pain, cramps, vomiting, diarrhea, anxiety, sleep problems, and cravings.

Note: I am compensated by Orexo to provide expertise and for my time to post.
It's good to see someone here on-site who can listen to the people and talk with people using this drug.

You'd also find yourself very at-home on suboxforum too, I'm sure.
I'm not linking to it or nothing, but a good Googler that types in Suboxforum would likely come up with the answer...
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