7:02AM BioDelivery Sciences announced that it has reached agreement with the FDA on the development program for BEM (BDSI) 2.22 : Co announced that it has reached agreement with FDA on the development program for BEMA Buprenorphine/Naloxone that should result in a New Drug Application 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 and development plan, which includes a pivotal pharmacokinetic study comparing BNX to Suboxone in normal volunteers and a supporting safety study in opioid dependent patients. 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.
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