BioDelivery Sciences International, Inc. (BDSI) has completed its study evaluating the safety and tolerability of BEMA Buprenorphine/Naloxone (BNX) in the treatment of opioid dependent patients.
"We are pleased with the outcome of this study," stated Dr. Andrew Finn, Executive Vice President of Product Development for BDSI in a news release. "Results demonstrate that BNX is easy to use and well tolerated. Importantly, the study also demonstrated that physicians could switch their opioid dependent patients from Suboxone to BNX without difficulty."
For study purposes, 249 patients were switched from Suboxone to BNX. Preliminary data indicate no unexpected adverse events and a favorable oral tolerability profile. The company says more detailed results will be provided in the future.
The results of this study complete the pivotal pharmacokinetic and clinical program for BNX, which BDSI believes will enable the submission of a New Drug Application (NDA) for BNX to the U.S. Food and Drug Administration (FDA) in mid-2013. BDSI expects to hold a pre-NDA meeting with the FDA in the next few months.
BNX utilizes the proven BioErodible MucoAdhesive Technology (BEMA) to efficiently and conveniently deliver buprenorphine for the management of opioid dependence and is formulated with naloxone to deter abuse.