BioDelivery Sciences International Inc. (BDSI) reported a positive outcome of its pivotal pharmacokinetic study for BEMA Buprenorphine/Naloxone or BNX, that is being developed for the potential treatment of opioid dependence and utilizes the patented BioErodible MucoAdhesive or BEMA technology to deliver buprenorphine combined with the opioid antagonist naloxone. Based on the trial's positive outcome, BDSI continues to anticipate that it would be in a position to submit a New Drug Application or NDA to the U.S. Food and Drug Administration or FDA for BNX during the second quarter of 2013.
The study, BNX-103, was designed to compare the relative bioavailability of buprenorphine and naloxone between BNX and the reference product, Suboxone.
Based on the FDA agreed upon 505(b)(2) pharmacokinetic regulatory pathway for the BNX program, the goals of the study were to demonstrate that two key pharmacokinetic parameters, maximum drug plasma concentration and total drug exposure, for buprenorphine were comparable to Suboxone, and that the same parameters for naloxone were similar or less than Suboxone. These goals were achieved in the trial.
"The results of this study allow us to not only move a step closer to the potential filing of an NDA for BNX in 2013, but also advance our commercialization considerations that include furthering our active partnership discussions for BNX," said Mark Sirgo, President and Chief Executive.
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