Endo Pharmaceuticals and BioDelivery Sciences announced that the Food and Drug Administration (FDA) has accepted for review its New Drug Application (NDA) for Belbuca (buprenorphine HCl) buccal film for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Two pivotal Phase 3 studies were conducted to demonstrate the safety and efficacy of Belbuca. The studies were double-blind, randomized, placebo-controlled, enriched-enrollment studies in patients with chronic lower back pain. One study (BUP-307) was conducted in opioid experienced patients, and the second study (BUP-308) was conducted in patients naïve to opioid therapy. Both studies met the primary efficacy endpoint of change from baseline to week 12 of mean daily pain intensity score from placebo (BUP-307; P<0.00001; BUP-308; P=0.001).
Buprenophine, a Schedule II controlled substance is a mu-opioid receptor partial agonist and a potent analgesic with a relatively long duration of action.