A pivotal pharmacokinetic study BNX-103 for BEMA Buprenorphine/Naloxone from Biodelivery Sciences Inc, has provided positive results in treatment of Opioid Dependence. The drug utilizes the patented BioErodible MucoAdhesive (BEMA) technology to deliver buprenorphine combined with the opioid antagonist naloxone. The goals of the study were to demonstrate that two key pharmacokinetic parameters, maximum drug plasma concentration (Cmax) and total drug exposure (area under the curve or AUC), 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 study. Based on the positive outcome of this study, the company anticipates that it will be in a position to submit a New Drug Application (NDA) to the FDA during the second quarter of 2013.