BioDelivery submits NDA for opioid dependence product

BioDelivery Sciences International Inc. (NASDAQ:BDSI) submitted an NDA to FDA for Bunavail buprenorphine naloxone to treat opioid dependence. The company submitted the product 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. ...