FDA accepts BioDelivery's Bunavail NDA

BioDelivery Sciences International Inc. (NASDAQ:BDSI) said FDA accepted for review an NDA for Bunavail buprenorphine naloxone to treat opioid dependence. The company expects a decision by early June 2014. The NDA was submitted under section 505(b)(2) of the Food, Drug and Cosmetic Act, which allows sponsors to reference data on safety and efficacy from the scientific literature or from previously approved products. Bunavail is a buprenorphine and naloxone polymer film formulated with BioDelivery's BioErodible MucoAdhesive (BEMA) transmucosal delivery system. ...