BioDelivery Sciences International, Inc. and Endo Pharmaceuticals Inc., a subsidiary of Endo International plc announced that the U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) for Belbuca (buprenorphine HCl) buccal film under development for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate.
Acceptance of the NDA for Belbuca has also triggered a $10 million milestone payment to BDSI from Endo Pharmaceuticals per the licensing agreement. BDSI will be eligible for an additional milestone payment of up to $50 million upon approval of the NDA. FDA has indicated a standard review designation for the NDA, and therefore, the action date is expected 10 months from the NDA submission (October 2015), which is standard for a 505(b)(2) application.
Additionally, the FDA recently accepted Belbuca as the proprietary name for buprenorphine HCl buccal film.
Source: Biodelivery Sciences
Filed Under: Drug Discovery