FDA Approves Belbuca Buccal Film for Chronic Pain
- By BSTQ Staff
The U.S. Food and Drug Administration has approved Belbuca (buprenorphine) buccal film for patients with severe chronic pain requiring daily, around-the-clock, longterm opioid treatment and for which alternative treatment options are inadequate. It is the first and only buprenorphine developed with a dissolving film that is absorbed through the inner lining of the cheek for chronic pain management.
Belbuca is a mu-opioid receptor partial agonist and a potent analgesic with a long duration of action that is delivered across the buccal mucosa. It is a Schedule III controlled substance, meaning it has been defined as having lower abuse potential than Schedule II drugs, a category that includes most opioid analgesics. Belbuca is expected to become commercially available in the U.S. during the first quarter of 2016 in seven dosage strengths, allowing for flexible dosing ranging from 75 μg to 900 μg every 12 hours, and enabling physicians to individualize titration and treatment based on the optimally effective and tolerable dose for each patient.
The approval is based on two double-blind, randomized, placebo-controlled Phase III studies in patients with moderate to severe chronic low back pain. A total of 1,559 opioid-experienced and opioid-naive patients took part in the trials that included an open-label period in which patients were titrated to a tolerated, effective dose of Belbuca and then randomized to either continue to receive Belbuca or a placebo. In both studies, Belbuca demonstrated a consistent, statistically significant improvement in patient-reported pain relief at every week from baseline to week 12 compared with the placebo. The most common adverse reactions reported by fewer than 5 percent of patients were nausea, constipation, headache, vomiting, fatigue, dizziness, somnolence, diarrhea, dry mouth and upper-respiratory tract infection.
