Endo and BioDelivery Sciences announced the submission of a New Drug Application (NDA) for buprenorphine HCl buccal film to the Food and Drug Administration (FDA) 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.
Buprenorphine HCl, a Schedule III controlled substance, is a partial opioid agonist with a long duration of action. The buccal film utilizes the Company’s BioErodible MucoAdhesive (BEMA) drug delivery technology to efficiently deliver buprenorphine across the buccal mucosa.
Data from two Phase 3 double-blind, randomized, placebo-controlled, enriched-enrollment studies demonstrated the safety and efficacy of buprenorphine HCl buccal film in patients with chronic lower back pain. Both studies (BUP-307 and BUP-308) achieved the primary efficacy endpoint of change from baseline to Week 12 of mean daily pain intensity score from placebo (BUP-307: P<0.00001 and BUP-308: P=0.001). Buprenorphine HCl buccal film was generally well tolerated and showed a low occurrence of common opioid-like side effects.