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Unread 11-10-2011, 02:33 PM   #1
NancyB
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Default BioDelivery Sciences (BDSI) - BEMA Buprenorphine for Opioid Addiction Update Thread

This looks like a product similar to the Suboxone film, "But BEMA Buprenorphine/Naloxone will use BDSI’s drug delivery platform, a small piece of film that administers medicine as it dissolves after being placed on the inside of the cheek. Suboxone is placed underneath the tongue."

It's still a ways off, but at least it looks like there may be competition for the film and hopefully that will mean lower prices.

http://www.medcitynews.com/2011/11/b...north-carolina
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Unread 11-10-2011, 02:55 PM   #2
vhappy
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Nancy or Tim,
Can you verify if my information is correct. My doctor told me he could no longer prescribe subutex, because I use the brand name. He said the makers of suboxone were not making it anymore because of the generics like teva and roxanne.

Because I use a pain clinic now, the doctor did not have the x number so I am not sure if it is him who could not prescribe suboxone or my insurance would not cover it. Now that Reckitt (?) is not making subutex he can prescribe suboxone. I am happy because I prefer the strips.

Don't want to send any mis-information is this correct? Not saying my doctor didn't have correct information, just not sure if I understood completly what he was explaining to me. He said he has patients that can only use name brand, because they experienced problems with generic, and when they went to have them filled were told they could not fill the subutex unless it was generic.....

Does this make sense?

vhappy
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Unread 11-10-2011, 03:53 PM   #3
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Hi vhappy, if a doctor is not certified s/he can prescribe Suboxone, Subutex (before they discontinued it) or generic Subutex off label. It's not limited to Subutex or the generics because all are FDA-approved only for opioid addiction. One caveat about prescribing any medication off label is that insurances are not obligated to cover it.

The only thing I can think of is if the doctor was prescribing Subutex and some insurance companies would only cover the generic because of it being less expensive, therefore they could only get the generic. (They couldn't have done that with Suboxone because there is no generic.) I have heard of people getting their doctor to contact the insurance company and explain a medical necessity for the brand name and the insurance company did then allow that to be covered.

Did I answer your question in there somewhere? lol Let me know.

Nancy
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Unread 11-10-2011, 04:03 PM   #4
vhappy
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Yes. I have my skype doctor and prescibing doctor 2 seperate people. Just really confirming that they did discontinue.

Thanks!
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Unread 11-10-2011, 05:51 PM   #5
vhappy
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Oh and also thanks for the article. Intresting to see what happen's. I noticed they compared it to R&B's opioid "dependence" product. Is addiction to dirty of a word to use? mmmm.......
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Unread 11-10-2011, 06:26 PM   #6
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Hi vhappy, opioid dependence is what the DSM-IV diagnosis is. So they have to go along with that. There's talk of when they revise the DSM-IV they will change it to Addiction. Too many people get confused because Opioid Dependence is Opioid Addiction; but Physical Dependence isn't addiction, it's just physical dependence.

I hope they do change it to addiction because that would really help distinguish between the two.

Nancy
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Unread 11-11-2011, 07:43 PM   #7
vhappy
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Thanks Nancy, I have the DSM-IV sitting in my office. I haven't picked it up in years. Brought it home last night. Interesting read also, but a little complicated to understand. I have only had to use it a few times, for paperwork purposes. That particular part has to be written in by the doctors for my paperwork, just can't read the writing half the time. It must be a requirement for med school.
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Unread 02-16-2012, 08:55 AM   #8
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More on BEMA Buprenorphine:

They'll have a patent through 2027.

http://www.marketwatch.com/story/bio...als-2012-02-16
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Unread 06-28-2012, 07:45 AM   #9
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Update on BEMA Buprenorphine/Naloxone:

http://www.marketwatch.com/story/bio...udy-2012-06-28

BioDelivery Sciences Announces Positive Results from BEMA Buprenorphine/Naloxone (BNX) Pharmacokinetic Study
--Results of the FDA recommended trial demonstrate dose proportionality ahead of the forthcoming pivotal pharmacokinetic study versus Suboxone --NDA on track for submission in the first half of 2013


RALEIGH, N.C., June 28, 2012 /PRNewswire via COMTEX/ -- BioDelivery Sciences International, Inc. BDSI +4.62% announced positive results of a recently completed pharmacokinetic study (BNX-106) examining the effects of multiple BEMA Buprenorphine/Naloxone (BNX) films administered concurrently. This study was part of the U.S. Food and Drug Administration (FDA) recommended program for a New Drug Application (NDA) for BNX.

The study confirmed that the buprenorphine pharmacokinetics were nearly identical following multiple BNX films applied at one time compared to an equivalent dose administered as a single film. Additionally, there was a linear relationship in buprenorphine pharmacokinetics across the dose range of BNX administered, meaning that as doses of BNX increased, there was a corresponding increase in the amount of buprenorphine in the plasma. Regarding the naloxone component of BNX, the study demonstrated that the exposure of naloxone is similar to the reference standard, Suboxone.

Overall, these results provide additional confidence that the doses selected for BDSI's upcoming pivotal pharmacokinetic study for BNX will produce similar buprenorphine pharmacokinetics as the reference product, Suboxone. This pivotal pharmacokinetic study is a critical component of the NDA.

"We are pleased to have again demonstrated the ability of our BEMA drug delivery technology to provide solid dose proportionality," said Dr. Andrew Finn, Executive Vice President of Product Development. "The outcome of this study not only satisfies the FDA's request for a multiple film evaluation, but it also enhances the probability of success for BNX in our upcoming pivotal pharmacokinetic study versus Suboxone."

BDSI expects to have key data results from the pivotal pharmacokinetic study versus Suboxone in late third quarter of this year after a mid-summer initiation. The final clinical requirement for the NDA, an open-label safety study, will initiate on time in the third quarter allowing BDSI to remain on track for an NDA filing in the first half of 2013.

About BEMA Buprenorphine/Naloxone (BNX) and Opioid Dependence

BNX is being developed for the treatment of opioid dependence and contains the same drug components as Suboxone, the only currently marketed formulation of buprenorphine and naloxone. Buprenorphine reduces the craving and withdrawal effects from the dependent opioid, and the opioid antagonist, naloxone, is present to deter abuse.

Opioid dependence is a significantly undertreated condition in the U.S., with nearly 2 million people dependent on prescription opioids according to the 2010 National Survey on Drug Use and Health, conducted by the U.S. Department of Health and Human Services. Suboxone (buprenorphine/naloxone), which was approved for the treatment of opioid dependence in 2002, has been shown to be a highly effective treatment option and, as a result, currently generates annual sales of more than $1.2 billion, growing over 20% in 2011 according to data from Wolters Kluwer. BDSI believes that BNX, which uses BDSI's proprietary BEMA delivery technology, has the potential to offer advantages over Suboxone and could seize a meaningful share of this rapidly growing market.

About BioDelivery Sciences International

BioDelivery Sciences International BDSI +4.62% is a specialty pharmaceutical company that is leveraging its novel and proprietary patented drug delivery technologies to develop and commercialize, either on its own or in partnerships with third parties, new applications of proven therapeutics. BDSI is focusing on developing products to meet unmet patient needs in the areas of pain management and oncology supportive care. BDSI's pain franchise currently consists of two products utilizing the patented BEMA technology. ONSOLIS (fentanyl buccal soluble film) is approved in the U.S., Canada, and the E.U. (where it will be marketed as BREAKYL), for the management of breakthrough pain in opioid tolerant, adult patients with cancer. The commercial rights are licensed to Meda for all territories worldwide except for Taiwan (licensed to TTY Biopharm) and South Korea (licensed to Kunwha Pharmaceutical Co.). BDSI's second pain product, BEMA Buprenorphine, is being developed for the treatment of moderate to severe chronic pain and is in development in a high dose formulation with naloxone for the treatment of opioid dependence. BEMA Buprenorphine for chronic pain is licensed on a worldwide basis to Endo Pharmaceuticals. BDSI's headquarters is located in Raleigh, North Carolina. For more information, visit www.bdsi.com .

BDSI® and BEMA® are registered trademarks of BioDelivery Sciences International, Inc. ONSOLIS® is a registered trademark of Meda Pharmaceuticals, Inc. BREAKYL is registered trademark of Meda Pharma GmbH & Co. KG.
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Unread 06-28-2012, 10:22 AM   #10
gotoffmdone
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So can pharmacies still order the brandname Subutex from RB. I thought the generic makers caused RB to stop mfg Subutex.

wayne
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Unread 06-28-2012, 10:28 AM   #11
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Quote:
Originally Posted by gotoffmdone View Post
So can pharmacies still order the brandname Subutex from RB. I thought the generic makers caused RB to stop mfg Subutex.

wayne
Hi Wayne, no, you're right, RB did stop making Subutex:

http://buprenorphine.samhsa.gov/Subu...ion9-16-11.pdf

Nancy
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Unread 07-02-2012, 11:10 AM   #12
anabolic1979
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yea they stopped making subutex because they were not making the large amounts of money they used to before it went generic. So instead of keeping it in production for people who prefer the name brand subutex they decided to say that bupe only products are unsafe and have a high abuse potential and to be safe use our suboxone film(which we will make billions on)... God i hate these companies...
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Unread 07-02-2012, 12:03 PM   #13
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Yep, it is called capitalism. No company can stay in business if they do not make a profit. Pharmaceutical companies are no different than any other business. It is common, once a medication has a generic, for the original company to discontinue the name brand. I, for one, am thankful that RB did the initial research, clinical studies, etc, and introduced the medication into use in the USA.

Before there was generic subutex folks were complaining about the cost. Now that there are generics on the market folks are complaining that the name brand is no longer available.

I am just plain thankful that this medication is available at all. It is a life-saver, that is for sure.

nan
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Unread 07-03-2012, 10:59 AM   #14
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I don’t think that most people understand the funding involved bringing a new medication to the public in this nation. Further, along with that they don’t understand how much of that cost is driven through government regulation and oversight. These medications cannot simply magically appear and the process provides a great many jobs for people. I do feel there could be steps taken to lower the costs some, but, it would be at the government level and the government simply isn’t going to give up that control or even part of it. And if we relied on the government to produce these medications, well they can’t even keep the potholes on the roads filled.
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Unread 09-13-2012, 01:50 PM   #15
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Update: 9/13/12

http://www.prnewswire.com/news-relea...169598796.html

BioDelivery Sciences Announces Positive Results of Pivotal Pharmacokinetic Study Comparing BEMA Buprenorphine/Naloxone (BNX) to Suboxone

NDA target remains on course for the second quarter of 2013

RALEIGH, N.C., Sept. 13, 2012 /PRNewswire/ -- BioDelivery Sciences International, Inc. (Nasdaq: BDSI) announced a positive outcome of the Company's pivotal pharmacokinetic study for BEMA Buprenorphine/Naloxone (BNX), which is being developed for the potential treatment of opioid dependence and utilizes the patented BioErodible MucoAdhesive (BEMA) technology to deliver buprenorphine combined with the opioid antagonist naloxone. Based on the positive outcome of this study, BDSI continues to anticipate that it will be in a position to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for BNX during the second quarter of 2013.

The study, BNX-103, was designed to compare the relative bioavailability of buprenorphine and naloxone between BNX and the reference product, Suboxone, which is currently approved for the maintenance treatment of opioid dependence. Based on the FDA agreed upon 505(b)(2) pharmacokinetic regulatory pathway for the BNX program, the goals of the study were to demonstrate that two key pharmacokinetic parameters, maximum drug plasma concentration (Cmax) and total drug exposure (area under the curve or AUC), for buprenorphine were comparable to Suboxone, and that the same parameters for naloxone were similar or less than Suboxone. These goals were achieved in the study.

"We are pleased with the outcome of this study and believe, based on our prior discussions with FDA, that the data supports a key component for our NDA," said Dr. Andrew Finn, Executive Vice President of Product Development. "The positive results of this study once again demonstrate the value and versatility of our BEMA drug delivery technology and its ability to effectively and efficiently deliver drugs to treat important medical conditions."

"The results of this study allow us to not only move a step closer to the potential filing of an NDA for BNX in 2013, but also advance our commercialization considerations that include furthering our active partnership discussions for BNX," said Dr. Mark A. Sirgo, President and Chief Executive Officer. "In the upcoming months, we will continue to evaluate our strategic options for the commercialization of BNX within and outside the U.S., including internal approaches, partnership or a combination of these. BNX is a significant asset to BDSI, and we believe, if approved, provides a relatively near-term opportunity to enter and capture a meaningful share of the over $1.2 billion and growing market for buprenorphine/naloxone by being the first film to compete directly against Suboxone."

About BioDelivery Sciences International
BioDelivery Sciences International (NASDAQ: BDSI) is a specialty pharmaceutical company that is leveraging its novel and proprietary patented drug delivery BEMA technology to develop and commercialize, either on its own or in partnerships with third parties, new applications of proven therapeutics. BDSI is focusing on developing products to meet unmet patient needs in the areas of pain management and addiction. BDSI's pain franchise currently consists of two products utilizing the patented BEMA technology. ONSOLIS (fentanyl buccal soluble film) is approved in the U.S., Canada, and the E.U. (where it will be marketed as BREAKYL), for the management of breakthrough pain in opioid tolerant, adult patients with cancer. The commercial rights are licensed to Meda for all territories worldwide except for Taiwan (licensed to TTY Biopharm) and South Korea (licensed to Kunwha Pharmaceutical Co.). BDSI's second pain product, BEMA Buprenorphine, is being developed for the treatment of moderate to severe chronic pain, and BDSI is also developing a high dose BEMA formulation of buprenorphine combined with naloxone for the treatment of opioid dependence. BEMA Buprenorphine for chronic pain is licensed on a worldwide basis to Endo. BDSI's headquarters is located in Raleigh, North Carolina. For more information, visit www.bdsi.com.

BDSI® and BEMA® are registered trademarks of BioDelivery Sciences International, Inc. ONSOLIS® is a registered trademark of Meda Pharmaceuticals, Inc. BREAKYLTM is registered trademark of Meda Pharma GmbH & Co. KG.

Cautionary Note on Forward-Looking Statements
This press release and any statements of representatives and partners of BioDelivery Sciences International, Inc. (the "Company") related thereto contain, or may contain, among other things, certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements with respect to the Company's plans, objectives, projections, expectations and intentions and other statements identified by words such as "projects," "may," "will," "could," "would," "should," "believe," "expects," "anticipate," "estimates," "intends," "plans," "potential" or similar expressions. These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks and uncertainties, including those detailed in the Company's filings with the Securities and Exchange Commission. Actual results (including, without limitation, with respect to timing and prospects for the clinical development program for, and commercialization of, BEMA Buprenorphine/Naloxone) may differ significantly from those set forth in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company's control). The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.
Readers are cautioned that market size estimates have been determined on the basis of market research and comparable product analysis, but no assurances can be given that such estimates are accurate.

SOURCE BioDelivery Sciences International, Inc.
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Unread 01-22-2013, 03:29 PM   #16
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http://bdsi.investorroom.com/2013-01...X-Safety-Study

BioDelivery Sciences Announces Completion of BNX Safety Study

Study shows favorable safety profile in opioid dependent patients transitioning from Suboxone

BNX remains on track for mid-year NDA submission


Jan 22, 2013

RALEIGH, N.C., Jan. 22, 2013 /PRNewswire/ -- BioDelivery Sciences International, Inc. (Nasdaq: BDSI) announced today the completion of its study evaluating the safety and tolerability of BEMA Buprenorphine/Naloxone (BNX) in the treatment of opioid dependent patients.

"We are pleased with the outcome of this study," stated Dr. Andrew Finn, Executive Vice President of Product Development for BDSI. "Results demonstrate that BNX is easy to use and well tolerated. Importantly, the study also demonstrated that physicians could switch their opioid dependent patients from Suboxone to BNX without difficulty."

The study included 249 patients who were switched from Suboxone to BNX. Preliminary data indicate no unexpected adverse events and a favorable oral tolerability profile. More detailed results will be provided in the future.

The results of this study complete the pivotal pharmacokinetic and clinical program for BNX, which BDSI believes will enable the submission of a New Drug Application (NDA) for BNX to the U.S. Food and Drug Administration (FDA) in mid-2013. BDSI expects to hold a pre-NDA meeting with the FDA in the next few months.

Dr. Finn concluded, "We look forward to the pre-NDA meeting as well as submission of our NDA, which is targeted for mid-year following availability of our final product stability data."

BNX utilizes the proven BioErodible MucoAdhesive Technology (BEMA) to efficiently and conveniently deliver buprenorphine for the management of opioid dependence and is formulated with naloxone to deter abuse. BDSI expects that BNX will offer an alternative to the only marketed buprenorphine/naloxone product, Suboxone, which generated sales approaching $1.5 billion in 2012, according to data from Wolters Kluwer. The BEMA technology has been utilized in the FDA approved product ONSOLIS (fentanyl buccal soluble film) as well as BDSI's BEMA Buprenorphine, which is in Phase 3 clinical development for chronic pain and was licensed to Endo Pharmaceuticals in January 2012.

About BioDelivery Sciences International
BioDelivery Sciences International (NASDAQ: BDSI) is a specialty pharmaceutical company that is leveraging its novel and proprietary patented drug delivery technologies to develop and commercialize, either on its own or in partnerships with third parties, new applications of proven therapeutics. BDSI is focusing on developing products to meet unmet patient needs in the areas of pain management and addiction. BDSI's pain franchise currently consists of two products utilizing the patented BEMA technology. ONSOLIS (fentanyl buccal soluble film) is approved in the U.S., Canada, and the E.U. (where it is marketed as BREAKYL), for the management of breakthrough pain in opioid tolerant, adult patients with cancer. The commercial rights are licensed to Meda for all territories worldwide except for Taiwan (licensed to TTY Biopharm) and South Korea (licensed to Kunwha Pharmaceutical Co.). BDSI's second pain product, BEMA Buprenorphine, is being developed for the treatment of moderate to severe chronic pain and is licensed on a worldwide basis to Endo Health Solutions. Additionally, BDSI is developing a high dose formulation of buprenorphine in combination with naloxone (BNX) for the treatment of opioid dependence. Both BEMA Buprenorphine and BNX are in Phase 3 clinical development. BDSI's headquarters is located in Raleigh, North Carolina. For more information visit www.bdsi.com.

Cautionary Note on Forward-Looking Statements
This press release and any statements of representatives and partners of BioDelivery Sciences International, Inc. (the "Company") related thereto contain, or may contain, among other things, certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements with respect to the Company's plans, objectives, projections, expectations and intentions and other statements identified by words such as "projects," "may," "will," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," "potential" or similar expressions. These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks and uncertainties, including those detailed in the Company's filings with the Securities and Exchange Commission and those that relate to the Company's ability to leverage the expertise of employees and partners to assist the Company in the execution of its strategy. Actual results (including, without limitation, the timing for and results of the proposed NDA submission for, and FDA review of, BNX) may differ significantly from those set forth in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company's control). The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.
BDSI® and BEMA® are registered trademarks of BioDelivery Sciences International, Inc. The BioDelivery Sciences logo is a trademark owned by BioDelivery Sciences International, Inc. ONSOLIS® is a registered trademark of Meda Pharmaceuticals, Inc. BREAKYL™ is a trademark owned by Meda Pharma GmbH & Co. KG. All other trademarks and tradenames are owned by their respective owners.
© BioDelivery Sciences International, Inc. All rights reserved.
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Unread 06-10-2013, 08:38 AM   #17
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Default Submission for BUNAVAIL on Track Following Positive Pre-NDA Meeting with FDA

http://www.sacbee.com/2013/06/10/548...announces.html

BioDelivery Sciences Announces NDA Submission for BUNAVAIL on Track Following Positive Pre-NDA Meeting with FDA
BUNAVAIL NDA submission continues on target for mid-summer 2013
By BioDelivery Sciences International, Inc.

Published: Monday, Jun. 10, 2013 - 4:12 am

RALEIGH, N.C., June 10, 2013 -- /PRNewswire/ -- BioDelivery Sciences International, Inc. (Nasdaq: BDSI) announced today that it engaged in a positive pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) regarding BUNAVAIL for the maintenance treatment of opioid dependence.

The positive outcome of the pre-NDA meeting allows BDSI to maintain its expectation of an NDA filing with FDA for BUNAVAIL in mid-summer 2013 as planned.

This scheduled meeting with FDA regarding the NDA submission of BUNAVAIL was undertaken to review the key data elements for the NDA, which includes data from a positive pivotal bioequivalence study versus Suboxone, an open-label safety study in patients switched from Suboxone film or tablets to BUNAVAIL, and product stability information. As a result of the feedback obtained, BDSI will continue forward with its NDA submission as planned.

"We are pleased with the outcome of our pre-NDA meeting where we reviewed the key elements of our NDA with the Agency," said Dr. Andrew Finn, Executive Vice President of Product Development for BDSI. "This outcome is allowing us to move confidently forward in finalizing and submitting our NDA."

BUNAVAIL utilizes BDSI's proprietary BioErodible MucoAdhesive (BEMA) technology to deliver buprenorphine for the maintenance treatment of opioid dependence, along with the opioid antagonist naloxone, which is intended to serve as an abuse deterrent. BDSI believes BUNAVAIL may offer meaningful advantages over existing treatments and could provide an alternative to the over 2 million people in the U.S. with opioid dependence. Currently, Suboxone is the only available film formulation of buprenorphine and naloxone, with the film formulation generating in excess of one billion dollars in sales in 2012. BUNAVAIL is positioned to be the next film formulation to enter the market. BDSI believes BUNAVAIL has the potential to generate peak sales in excess of $250 million.

About BioDelivery Sciences International

BioDelivery Sciences International (NASDAQ: BDSI) is a specialty pharmaceutical company that is leveraging its novel and proprietary patented drug delivery technologies to develop and commercialize, either on its own or in partnerships with third parties, new applications of proven therapeutics. BDSI is focusing on developing products to meet unmet patient needs in the areas of pain management and addiction.

BDSI's pain franchise currently consists of three products, two of which utilize the patented BioErodible MucoAdhesive (BEMA) drug delivery technology. ONSOLIS (fentanyl buccal soluble film) is approved in the U.S., Canada, and the E.U. (where it is marketed as BREAKYL), for the management of breakthrough pain in opioid tolerant, adult patients with cancer. The commercial rights are licensed to Meda for all territories worldwide except for Taiwan (licensed to TTY Biopharm) and South Korea (licensed to Kunwha Pharmaceutical Co.).

BDSI's second pain product using the BEMA technology, BEMA Buprenorphine, is being developed for the treatment of moderate to severe chronic pain and is licensed on a worldwide basis to Endo Health Solutions. BDSI's third pain product in development is Clonidine Topical Gel for the treatment of painful diabetic neuropathy, which was recently licensed from Arcion Therapeutics.

Additionally, BDSI is developing BUNAVAIL, a high dose formulation of buprenorphine in combination with naloxone for the treatment of opioid dependence. Both BEMA Buprenorphine and BUNAVAIL are in Phase 3 clinical development, and Clonodine Topical Gel is in Phase 2 clinical development.

BDSI's headquarters is located in Raleigh, North Carolina. For more information visit www.bdsi.com.

Cautionary Note on Forward-Looking Statements

This press release, the presentation referred to herein, and any statements of representatives and partners of BioDelivery Sciences International, Inc. (the "Company") related thereto contain, or may contain, among other things, certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements with respect to the Company's plans, objectives, projections, expectations and intentions and other statements identified by words such as "projects," "may," "will," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," "potential" or similar expressions. These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks and uncertainties, including those detailed in the Company's filings with the Securities and Exchange Commission and those that relate to the Company's ability to leverage the expertise of employees and partners to assist the Company in the execution of its strategy. Actual results (including, without limitation, the timing for and results of the clinical trials and proposed NDA submissions for, and FDA review of, the Company's products in development) may differ significantly from those set forth in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company's control). The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.

Readers are cautioned that peak sales and market size estimates have been determined on the basis of market research and comparable product analysis, but no assurances can be given that such estimates are accurate or that such sales levels will be achieved, if at all.

BDSI® and BEMA® are registered trademarks of BioDelivery Sciences International, Inc. The BioDelivery Sciences logo and BUNAVAIL™ are trademarks owned by BioDelivery Sciences International, Inc. ONSOLIS® is a registered trademark of Meda Pharmaceuticals, Inc. BREAKYL™ is a trademark owned by Meda Pharma GmbH & Co. KG. All other trademarks and tradenames are owned by their respective owners.

© BioDelivery Sciences International, Inc. All rights reserved.

SOURCE BioDelivery Sciences International, Inc.
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Unread 08-01-2013, 07:43 AM   #18
NancyB
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http://www.marketwatch.com/story/bio...ail-2013-08-01

BioDelivery Sciences Announces Submission of NDA for BUNAVAIL

First buprenorphine naloxone buccal film for the maintenance treatment of opioid dependence


RALEIGH, N.C., Aug. 1, 2013 /PRNewswire via COMTEX/ -- BioDelivery Sciences International, Inc. BDSI +1.17% announced that yesterday it submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for BUNAVAIL (buprenorphine naloxone buccal film) for the maintenance treatment of opioid dependence. Under the 505(b)(2) regulatory statute, BUNAVAIL will be subject to a ten month review.

BUNAVAIL uses BDSI's patented BioErodible MucoAdhesive (BEMA) drug delivery technology to deliver buprenorphine across the buccal mucosa (inside lining of the cheek). BUNAVAIL is formulated with the abuse deterrent agent naloxone and is designed to efficiently and conveniently deliver buprenorphine while potentially overcoming some of the challenges with other dosage forms.

"The submission of the NDA for BUNAVAIL marks another major milestone for BDSI as we seek FDA approval of a second product using our BEMA technology," said Dr. Mark A. Sirgo, President and Chief Executive Officer. "Opioid dependence is a serious and growing healthcare problem in this country affecting over 2 million people in the U.S. There remains a need for better dosage forms for the delivery of buprenorphine to these patients, an opportunity for which BDSI hopes to capitalize. It is our intention to bring to market a product that we believe positions us to significantly participate in this $1.5 billion and growing market."

Dr. Sirgo continued, "With our NDA filed we will continue to evaluate our strategic options for the commercialization of BUNAVAIL in the U.S., which include partnership, internal approaches or a combination of these. We will provide updates on our strategic direction as the year progresses."

The clinical program for BUNAVAIL, as agreed upon with FDA, included a bioequivalence study to Suboxone tablets and a study assessing the safety and tolerability of BUNAVAIL in opioid dependent subjects switched from Suboxone film or tablets to BUNAVAIL.

"We are very pleased to have submitted our NDA for BUNAVAIL," said Dr. Andrew Finn, Executive Vice President of Product Development. "If approved, BUNAVAIL will be the first dosage form for the treatment of opioid dependence that does not require under the tongue (or sublingual) administration. Utilizing the BEMA drug delivery technology, BUNAVAIL films adhere to the inside of the cheek and dissolve quickly. By keeping BUNAVAIL in contact with the mucosal surface, our data demonstrates that buprenorphine absorption is optimized and provides comparable plasma concentrations of buprenorphine to Suboxone with considerably lower doses."

Dr. Finn concluded, "In a clinical study we conducted in which 249 opioid dependent subjects switched from Suboxone tablets or films to BUNAVAIL, the majority of patients found BUNAVAIL to be easy to use and pleasant tasting - two important attributes that may represent improvements over current therapies in patients being treated for opioid dependence."

About BUNAVAIL and Opioid Dependence

BUNAVAIL is the first and only buccal (adhering to the inside of the cheek) formulation of buprenorphine and naloxone and has been developed for the maintenance treatment of opioid dependence. BUNAVAIL utilizes BDSI's proven and patent-protected BioErodible MucoAdhesive (BEMA) drug delivery technology.

Buprenorphine, the active ingredient in BUNAVAIL, is poorly absorbed orally from the gastrointestinal tract; however, it is absorbed within the oral cavity transmucosally (across the cheek or under the tongue). Buprenorphine reduces the craving and withdrawal effects from the dependent opioid, and the opioid antagonist, naloxone, is present to deter abuse.

Opioid dependence is a significantly undertreated condition in the U.S., with nearly 2 million people dependent on prescription opioids according to the 2010 National Survey on Drug Use and Health, conducted by the U.S. Department of Health and Human Services. Suboxone, which was approved for the treatment of opioid dependence in 2002, has been shown to be a highly effective treatment option and, as a result, currently generates annual sales of more than $1.5 billion according to data from Wolters Kluwer.

About BioDelivery Sciences International

BioDelivery Sciences International BDSI +1.17% is a specialty pharmaceutical company that is leveraging its novel and proprietary patented drug delivery technologies to develop and commercialize, either on its own or in partnerships with third parties, new applications of proven therapeutics. BDSI is focusing on developing products to meet unmet patient needs in the areas of pain management and addiction.

BDSI's pain franchise currently consists of three products, two of which utilize the patented BioErodible MucoAdhesive (BEMA) drug delivery technology. ONSOLIS (fentanyl buccal soluble film) is approved in the U.S., Canada, E.U. (where it is marketed as BREAKYL) and Taiwan (where it is marketed as PAINKYL), for the management of breakthrough pain in opioid tolerant, adult patients with cancer. The commercial rights are licensed to Meda for all territories worldwide except for Taiwan (licensed to TTY Biopharm) and South Korea (licensed to Kunwha Pharmaceutical Co.).

BDSI's second pain product using the BEMA technology, BEMA Buprenorphine, is in Phase 3 clinical trials for the treatment of moderate to severe chronic pain and is licensed on a worldwide basis to Endo Health Solutions. BDSI's third pain product in development is Clonidine Topical Gel for the treatment of painful diabetic neuropathy and was recently licensed from Arcion Therapeutics.

In August 2013, BDSI filed an NDA for BUNAVAIL, a high dose formulation of buprenorphine in combination with naloxone for the maintenance treatment of opioid dependence. Under the 505(b)(2) regulatory statute, BUNAVAIL i subject to a ten month review.

BDSI's headquarters is located in Raleigh, North Carolina. For more information visit www.bdsi.com.

Cautionary Note on Forward-Looking Statements

This press release, the presentation referred to herein, and any statements of representatives and partners of BioDelivery Sciences International, Inc. (the "Company") related thereto contain, or may contain, among other things, certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements with respect to the Company's plans, objectives, projections, expectations and intentions and other statements identified by words such as "projects," "may," "will," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," "potential" or similar expressions. These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks and uncertainties, including those detailed in the Company's filings with the Securities and Exchange Commission and those that relate to the Company's ability to leverage the expertise of employees and partners to assist the Company in the execution of its strategy. Actual results (including, without limitation, the timing for and results of the FDA's review of BUNAVAIL) may differ significantly from those set forth in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company's control). The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.

BDSI� and BEMA� are registered trademarks of BioDelivery Sciences International, Inc. The BioDelivery Sciences logo and BUNAVAIL(TM) are trademarks owned by BioDelivery Sciences International, Inc. ONSOLIS� is a registered trademark of Meda Pharmaceuticals, Inc. BREAKYL(TM) is a trademark owned by Meda Pharma GmbH & Co. KG. PAINKYLTM is a trademark owned by TTY Biopharm. All other trademarks and tradenames are owned by their respective owners.

SOURCE BioDelivery Sciences International, Inc.

Copyright (C) 2013 PR Newswire. All rights reserved
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Unread 08-02-2013, 10:05 PM   #19
Maggiepi
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Nancy
Wonder if dr's that presubscribe film will be able to prescribe this? Or if they will b required to go through the "classes" for it? Cheaper pricing? Gosh I hope. From what I'm reading this will be out around September?
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Unread 08-02-2013, 10:36 PM   #20
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Hi Maggiepi, any doctor who is already certified to prescribe buprenorphine for opiate addiction will be able to prescribe BUNAVAIL also.

From this line it looks like there will be a review next year for it. Under the 505(b)(2) regulatory statute, BUNAVAIL will be subject to a ten month review.

Another bupe medication that is approved is another buprenorphine/naloxone tablet - not a generic - call Subzolv.

It's supposed to be less expensive and they'll have a patient assistance program also. Here's the thread that has all the information we know so far:
http://www.addictionsurvivors.org/vb...ad.php?t=28006

Hope that helps.

Nancy
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Unread 10-09-2013, 07:55 AM   #21
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BioDelivery Sciences Says FDA Accepts BUNAVAIL NDA For Filing - Quick Facts

http://www.rttnews.com/2200188/biode...ick-facts.aspx

10/9/2013 7:15 AM ET
BioDelivery Sciences International Inc. (BDSI) announced Wednesday that its New Drug Application or NDA for BUNAVAIL or buprenorphine naloxone buccal film for the maintenance treatment of opioid dependence has been accepted for filing by the U.S. Food and Drug Administration or FDA, indicating that the application is sufficiently complete to permit a substantive review.

Based on timelines established by the Prescription Drug User Fee Act or PDUFA, the review of the BUNAVAIL NDA is expected to be completed by early June 2014.

BUNAVAIL utilizes BDSI's proprietary BioErodible MucoAdhesive or BEMA technology to deliver buprenorphine for the maintenance treatment of opioid dependence, along with the opioid antagonist naloxone, which is intended to serve as an abuse deterrent.

BUNAVAIL, if approved by the FDA, would be the first buccal film formulation of buprenorphine/naloxone to enter the market. BDSI believes that BUNAVAIL has the potential to generate annual peak U.S. sales up to $250 million.

The NDA for BUNAVAIL is supported by a bioequivalence study versus Suboxone and an open-label safety study in 249 patients switched from Suboxone film or tablets to BUNAVAIL.
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