Navigation Links
BioDelivery Sciences Announces Positive Results of Pivotal Pharmacokinetic Study Comparing BEMA Buprenorphine/Naloxone (BNX) to Suboxone
Date:9/13/2012

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.

(Logo: http://photos.prnewswire.com/prnh/20110217/CL49801LOGO )

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.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. BioDelivery Sciences Announces Positive Results from BEMA Buprenorphine/Naloxone (BNX) Pharmacokinetic Study
2. BioDelivery Sciences and Endo Health Solutions Announce Initiation of Enrollment in the Phase 3 Program for BEMA Buprenorphine for Chronic Pain
3. BioDelivery Sciences to Present at the 2012 Wedbush PacGrow Lifesciences Management Access Conference
4. BioDelivery Sciences Announces Completion of Enrollment in Pivotal Pharmacokinetic Study of BEMA Buprenorphine/Naloxone Compared to Suboxone
5. BioDelivery Sciences to Present at the Stifel Nicolaus 2012 Healthcare Conference
6. Pressure BioSciences, Inc. and Target Discovery, Inc. Expand Strategic License Agreement and Collaboration Supporting TDIs Planned Offering of Personalized Medicine Clinical Diagnostic Services
7. Structural Trends to Profoundly Change Life Sciences Industry, Genpact Study Shows
8. University of Maryland BioPark Announces MedImmunes Dr. Bahija Jallal as Newest Member of Board of Directors for UM Health Sciences Research Park
9. Neurocrine Biosciences Announces Conference Call and Webcast to Present First Quarter 2012 Financial Results
10. Axis Global Logistics Names Mr. Thomas Brennan, Vice President Strategic Accounts & Life Sciences
11. Amarantus BioSciences to Present at the New York Biotechnology Association (NYBA) 21st Annual Meeting on May 2nd, 2012
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/27/2016)... , April 27, 2016 Transparency ... "Skincare Devices Market - Global Industry Analysis, Size, Share, ... the report, the global skincare devices market was valued ... to expand at a CAGR of 10.1% from 2015 ... Browse the full Skincare Devices Market (Treatment Device ...
(Date:4/27/2016)... Kan. , April 27, 2016  Bayer ... , a senior from the University of Florida ... of the Bayer Excellence in Communication Award (BECA). ... schools, which were awarded a total of $70,000 ... the last four years, Bayer has provided a ...
(Date:4/27/2016)... April 27, 2016 Oasmia ... developer of a new generation of drugs within ... survival results for Paclical/Apealea in the Phase III ... with epithelial ovarian cancer. These preliminary results showed ... combination with carboplatin versus Taxol in combination with ...
Breaking Medicine Technology:
(Date:4/28/2016)... ... April 28, 2016 , ... In 2011, TIME magazine named Herr ... field of biomechatronics, technology that marries human physiology with electromechanics. He continues that work ... also the Founder of BionX , a leader in the field of prosthetic ...
(Date:4/28/2016)... ... April 28, 2016 , ... One way to ignore solid evidence is ... true. But we toss the baby out with the bathwater when we ignore all ... identifying higher-quality studies and otherwise making better use of education policy research. , “When ...
(Date:4/28/2016)... ... April 28, 2016 , ... Anzu®, ... announced a new Residency Education & Collaboration Platform for hospitals and medical ... and a host of collaboration tools designed to improve patient outcomes through ...
(Date:4/28/2016)... ... April 28, 2016 , ... Accreditation Commission for Health Care ... (COPA) to develop a comprehensive Specialty Pharmacy Accreditation with Distinction in Oncology. This ... ACHC provides a wide range of pharmacy accreditation services that assess the business ...
(Date:4/28/2016)... MO (PRWEB) , ... April 28, 2016 , ... Denise McCormick Baich had written poetry ... 2009 the poetry arrived again much like a tsunami and took on a more spiritual ... to her encouraged her to do more with it than just file it away. Friends ...
Breaking Medicine News(10 mins):