Buprenorphine Film Approved by FDA

The FDA today approved Endo Pharmaceuticals and BioDelivery Sciences’ buprenorphine buccal film (Belbuca) for the management of chronic pain severe enough to require daily, around-the-clock opioid treatment and for which alternative therapies are inadequate.

As the first and only dissolving buprenorphine film to receive the FDA’s nod, Belbuca was developed using BioDelivery Sciences’ BioErodible MucoAdhesive technology, which allows the drug to be efficiently delivered across the inside lining of the cheek.

The agency based its approval on data from a pair of phase 3 studies in which the drug’s safety and efficacy were demonstrated in a total of 1559 patients with moderate to severe chronic low back pain. In both studies, the use of Belbuca yielded a consistent, statistically significant improvement in patient-reported pain relief at every week from baseline to week 12 compared with placebo.

The most common adverse reactions reported by trial participants treated with Belbuca include nausea, constipation, headache, vomiting, fatigue, dizziness, somnolence, diarrhea, dry mouth, and upper respiratory tract infection.

“The availability of new, convenient, and flexible treatment options is important for patients whose lives are burdened by chronic pain, a debilitating condition that affects more Americans than diabetes, heart disease, and cancer combined,” said Richard L. Rauck, MD, Director of Carolinas Pain Institute, in a press release. “Belbuca provides a unique approach for chronic pain management, combining the proven efficacy and established safety of buprenorphine with a novel buccal film delivery system that adds convenience and flexibility.”

The manufacturers plan to launch Belbuca in 7 dosage strengths during the first quarter of 2016.