News Breaks |
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| January 22, 2013 |
| 07:04 EDT |  | BDSI | BioDelivery 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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News For BDSI From The Last 14 Days Check below for free stories on BDSI the last two weeks. |
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| There are no results for BDSI |
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