BioDelivery (BDSI) Reaches Agreement w/ FDA Over BEMA BNX Program
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BioDelivery Sciences International, Inc. (Nasdaq: BDSI) today announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) on the development program for BEMA Buprenorphine/Naloxone (BNX) that should result in a New Drug Application (NDA) filing for the treatment of opioid dependence in the first half of 2013.
BDSI recently met with the FDA and discussed the results of its recently completed pharmacokinetic study (BNX-102) and development plan, which includes a pivotal pharmacokinetic study (BNX-103) comparing BNX to Suboxone in normal volunteers and a supporting safety study in opioid dependent patients. The FDA concurred with BDSI's strategy while requesting one additional, non-comparative pharmacokinetic study examining the effects of multiple BNX films administered concurrently. A similar study was requested and completed as part of the NDA for BDSI's approved product ONSOLIS.
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BDSI recently met with the FDA and discussed the results of its recently completed pharmacokinetic study (BNX-102) and development plan, which includes a pivotal pharmacokinetic study (BNX-103) comparing BNX to Suboxone in normal volunteers and a supporting safety study in opioid dependent patients. The FDA concurred with BDSI's strategy while requesting one additional, non-comparative pharmacokinetic study examining the effects of multiple BNX films administered concurrently. A similar study was requested and completed as part of the NDA for BDSI's approved product ONSOLIS.
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