BioDelivery Sciences International, Inc. (BDSI) Demonstrates Positive Results in Recent Study
BioDelivery Sciences International recently completed an FDA recommended trial as part of the New Drug Application (NDA) to examine the effects of multiple BEMA Buprenorphine/Naloxone (BNX) films administered concurrently. Results of the pharmacokinetic study were positive, indicating that the NDA is on track for submission in early 2013. BDSI expects to have key data from the study in the third quarter of 2012, and the final clinical requirement for an open label study will be initiated at this time. The intention of the study was to examine dose proportionality ahead of the forthcoming pharmacokinetic study. The results confirmed that the…