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January 22, 2013
07:04 EDTBDSIBioDelivery Sciences announces completion of BNX safety study
BioDelivery Sciences International announced the completion of its study evaluating the safety and tolerability of BEMA Buprenorphine/Naloxone in the treatment of opioid dependent patients. 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. 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 for BNX to the U.S. Food and Drug Administration in mid-2013. BDSI expects to hold a pre-NDA meeting with the FDA in the next few months.
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