Published on August 20, 2012 at 12:15 PM
BioDelivery Sciences International, Inc. (Nasdaq: BDSI) announced that enrollment and the clinical portion of the pivotal pharmacokinetic study for BEMA Buprenorphine/Naloxone (BNX) for the treatment of opioid dependence has been completed.
As agreed with the U.S. Food and Drug Administration (FDA) in February 2012, the study, referred to as BNX-103, was designed to compare the relative bioavailability of buprenorphine and naloxone from BNX with the reference product Suboxone. Meeting those requirements will represent a positive outcome of that study. All subjects have been dosed and the analytical work (i.e., plasma sample analysis) is in process. BDSI expects to report results from this pivotal pharmacokinetic study before the end of September.
The open-label safety study, which is the last clinical requirement for this program, is expected to complete by year-end. Availability of the necessary product stability data for BNX in the first quarter of 2013 will be followed by submission of the NDA in the second quarter.
SOURCE BioDelivery Sciences International, Inc.