Buprenorphine/Naloxone Buccal Film Accepted for NDA Filing
BioDelivery Sciences International announced that its New Drug Application (NDA) for Bunavail (buprenorphine and naloxone buccal film) has been accepted for the maintenance treatment of opioid dependence. Bunavail is the first buccal formulation of buprenorphine and naloxone.
Bunavail utilizes the company's proprietary BioErodible MucoAdhesive (BEMA) technology to deliver buprenorphine along with naloxone. Currently, Suboxone sublingual film (Reckitt Benckiser) is the only available film formulation of buprenorphine and naloxone.
Buprenorphine is a Schedule III controlled substance that acts as a partial agonist of the mu-opioid receptor. It is a potent analgesic with a relatively long duration of action. Naloxone is an opioid antagonist that serves as an abuse deterrent.
Review of the Bunavail NDA is expected to be completed by early June 2014.For more information call (919) 582-9050 or visit BDSI.com.