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BioDelivery Sciences Initiates Confirmatory Pharmacokinetic Study of BEMA Buprenorphine/Naloxone Compared to Suboxone
Date:11/10/2011

RALEIGH, N.C., Nov. 10, 2011 /PRNewswire/ -- BioDelivery Sciences International, Inc. (Nasdaq: BDSI) announced that it has initiated a confirmatory pharmacokinetic study of a formulation of buprenorphine and naloxone utilizing BDSI's patented BioErodible MucoAdhesive (BEMA) drug delivery technology.  

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

The study, BNX-102, will be used to select the final doses of BEMA Buprenorphine/Naloxone to be used in the pivotal bioequivalence study compared to Suboxone which is anticipated to start in January of 2012.

BEMA Buprenorphine/Naloxone is being developed for the treatment of opioid dependence and contains the same drug components as Suboxone but will utilize BDSI's proven BEMA technology to efficiently and conveniently deliver buprenorphine.  Currently, Suboxone generates sales in the U.S. in excess of $1 billion annually and is the only marketed formulation of buprenorphine/naloxone.  

Results of BNX-101, an earlier pharmacokinetic study reported in September of this year, demonstrated the ability of the BEMA formulation to meet the key pharmacokinetic goal of delivering plasma concentrations of buprenorphine in the range needed to treat opioid dependence, while minimizing the exposure of naloxone, an abuse deterrent component.  Formulation modifications were made for commercial scale manufacturing purposes and to help ensure the selection of a formulation providing the greatest likelihood of demonstrating bioequivalence compared to Suboxone.  

Assuming a positive outcome of BNX-102, and factoring in the potential need to discuss findings or further plans with the U.S. Food and Drug Administration, the pivotal bioequivalence study (BNX-103) required for a New Drug Application (NDA) is targeted to
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SOURCE BioDelivery Sciences International, Inc.
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