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BioDelivery Sciences Provides Business Update and Summary of Third Quarter Results of Operations
Date:11/8/2012

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  • BNX - Opioid Dependence.  BDSI announced a positive outcome of the Company's pivotal pharmacokinetic study for BNX, which is being developed for the treatment of opioid dependence and utilizes the patented BioErodible MucoAdhesive (BEMA) technology to deliver buprenorphine combined with the opioid antagonist naloxone.  The study, BNX-103, was designed to compare the relative bioavailability of buprenorphine and naloxone between BNX and the reference product, Suboxone. 

    In the upcoming months, BDSI will continue to evaluate its strategic options for the commercialization of BNX in the U.S. and rest of world, including internal approaches, partnership or a combination of these.
    • Opioid Dependence Market Developments.  In September, Reckitt Benckiser, the manufacturer of Suboxone sublingual tablets and films, announced that it had notified the FDA that they will voluntarily discontinue the distribution of Suboxone tablets in the U.S.  The decision was reportedly due to accumulating data demonstrating significantly lower rates of accidental pediatric exposure with Suboxone films compared with their tablet formulation due to the child-resistant, unit-dose packaging of the film versus a multi-dose bottle for the tablets.  As for BNX and our FDA approved product ONSOLIS, child-resistant, unit-dose packaging has always been in place.
       
      Assuming ultimate FDA approval, BNX is expected to compete in the opioid dependence market against Suboxone; therefore, the recent steps taken by Reckitt may significantly and favorably alter the dynamics of the market for BNX.  Specifically, we believe this development will cause the market for Suboxone to convert entirely to the film formulation, likely substantially limiting the impact of potential future generic tablets, which are expected to possibly enter the market in the first half of 201
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    SOURCE BioDelivery Sciences International, Inc.
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