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BioDelivery Sciences Announces Completion of BNX Safety Study
Date:1/22/2013

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.

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"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, Su
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SOURCE BioDelivery Sciences International, Inc.
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