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BioDelivery Sciences and FDA Reach Agreement on BNX Development Plan
Date:2/28/2012

RALEIGH, N.C., Feb. 28, 2012 /PRNewswire/ -- 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.

"By proactively meeting with the FDA to discuss and confirm our NDA requirements for BNX, we believe we have increased the likelihood of a timely filing and approval for a promising product that could offer both patients and healthcare providers with a convenient and effective alternative treatment option for opioid dependence," stated Dr. Mark A. Sirgo, President and Chief Executive Officer of BDSI.

Following the multi-film study, BDSI plans on initiating the pivotal pharmacokinetic study and the safety study by mid-2012. Results of the pivotal pharmacokinetic study are anticipated to be available within three months of initiation and the safety study by early 2013. This will allow for an anticipated NDA filing in the first half of 2013.

About BEMA Buprenorphine/Naloxone (BNX) and Opioid Dependence

BNX is being developed for the treatment of opioid dependence and contains t
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SOURCE BioDelivery Sciences International, Inc.
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