BioDelivery Sciences International (BDSI) has successfully filed an NDA with the FDA for Bunavail (buprenorphine naloxone buccal film) for the maintenance treatment of opioid dependence Based on timelines established by the Prescription Drug User Fee Act (PDUFA), the review of the Bunavail NDA is expected to be completed by early June 2014.

Bunavail utilizes BDSI’s proprietary BioErodible MucoAdhesive (BEMA) technology to deliver buprenorphine for the maintenance treatment of opioid dependence, along with the opioid antagonist naloxone, which is intended to serve as an abuse deterrent. Bunavail was designed to efficiently and conveniently deliver buprenorphine while potentially overcoming some of the challenges with other dosage forms.

Currently, Suboxone sublingual film is the only available film formulation of buprenorphine and naloxone and is estimated to have generated sales in excess of $1 billion in the past 12 months. 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 $250 million.