American pharmaceutical company BioDelivery Sciences (BDSI) has completed the safety and tolerability trial of BEMA Buprenorphine/Naloxone (BNX), which is indicated for the treatment of opioid dependent patients.
BDSI claims that BNX, which uses BioErodible MucoAdhesive Technology (BEMA) and is formulated with naloxone to deliver buprenorphine for opioid dependence management, can be considered as an alternative to the only marketed buprenorphine/naloxone product, Suboxone.
The preliminary data of the evaluation study, conducted on 249 patients by switching them from Suboxone to BNX, demonstrated favorable oral tolerability without any signs of unexpected adverse events.
Commenting on the study outcome, BDSI executive vice president of product development Dr. Andrew Finn said the results clearly state that the drug is both 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," Dr. Finn said.
Based on the study, the company is planning to file a New Drug Application (NDA) for BNX with the US Food and Drug Administration (FDA) in mid-2013 preceded by a pre-NDA meeting.
"We look forward to the pre-NDA meeting as well as submission of our NDA, which is targeted for mid-year following availability of our final product stability data," added Dr. Finn.