BioDelivery Sciences' New Drug Application for Bunavail - buprenorphine naloxone buccal film - for the maintenance treatment of opioid dependence has been accepted for filing by the FDA. Review of the NDA is expected to be completed by early June 2014. Bunavail, if approved by the FDA, would be the first buccal film formulation of buprenorphine/naloxone to enter the market. BDSI believes that Bunavail has the potential to generate annual peak U.S. sales up to $250M.
- Pharmaceuticals & Drug Trials