FDA Approves Belbuca for Chronic Pain Management

FDA Approves Belbuca for Chronic Pain Management
FDA Approves Belbuca for Chronic Pain Management

Endo announced that the Food and Drug Administration (FDA) has approved Belbuca (buprenorphine) buccal film for use in patients with chronic pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Belbuca is the first buprenorphine formulation developed as a dissolving film absorbed through the inner lining of the cheek for chronic pain management. It is a mu-opioid receptor partial agonist and strong analgesic with a long duration of action. Belbuca uses BDSI's patented BioErodible MucoAdhesive (BEMA) technology that delivers buprenorphine across the buccal mucosa efficiently.

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The FDA's approval was based on two double-blind, randomized, placebo-controlled, enriched-enrollment Phase 3 studies in patients with moderate to severe chronic low back pain (n=1,559). In the trials, patients were titrated to a tolerated, effective dose of Belbuca during an open-label period and then randomized to either continue on Belbuca or receive a placebo buccal film.  Treatment with Belbuca showed a consistent, statistically significant improvement in patient-reported pain relief at every week from baseline to Week 12 vs. placebo for both studies.

Belbuca, a Schedule III substance, will be available as 75mcg, 150mcg, 300mcg, 450mcg, 600mcg, 750mcg, and 900mcg strengths in 60-count cartons. It is anticipated to launch in the first quarter of 2016.

For more information call (800) 462-3636 or visit Belbuca.com.

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