ARTICLE | Clinical News

Buprenorphine buccal film regulatory update

November 9, 2015 8:00 AM UTC

FDA approved an NDA from Endo for Belbuca buprenorphine buccal film to manage pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate. The approval triggered a $50 million milestone payment to BioDelivery under a 2012 deal granting Endo exclusive, worldwide rights to develop and commercialize the product to treat chronic pain (see BioCentury, Jan. 9, 2012). The partners expect to launch Belbuca in 1Q16. ...