BioDelivery Sciences International (BDSI) had a positive pre-New Drug Application (NDA) meeting with the FDA regarding Bunavail for the maintenance treatment of opioid dependence.
The positive outcome of the pre-NDA meeting allows BDSI to maintain its expectation of an NDA filing with the FDA for Bunavail in mid-summer 2013 as planned.
This FDA meeting was undertaken to review the key data elements for the NDA, which includes data from a positive pivotal bioequivalence study versus Suboxone, an open-label safety study in patients switched from Suboxone film or tablets to Bunavail, and product stability information.
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. BDSI believes Bunavail may offer advantages over existing treatments and could provide an alternative to the over 2 million people in the U.S. with opioid dependence. Currently, Suboxone is the only available film formulation of buprenorphine and naloxone, with the film formulation generating in excess of $1 billion in sales in 2012.