Endo Pharmaceuticals Inc., a subsidiary of Endo International plc, and BioDelivery Sciences International, Inc. (NASDAQ: BDSI), announced today that the U.S. 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™, which 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, is expected to be 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. This enables physicians to individualize titration and treatment based on the optimally effective and tolerable dose for each patient.
The FDA approval of Belbuca was based on two double-blind, randomized, placebo-controlled, enriched-enrollment phase 3 studies in patients with moderate to severe chronic low back pain. In these pivotal trials, a total of 1,559 opioid-experienced (study BUP-307) and opioid-naive (study BUP-308) patients received study drug. The trials included an open-label period in which patients were titrated to a tolerated, effective dose of Belbuca and then randomized to either continue on Belbuca or receive a placebo buccal film.
In both studies, Belbuca demonstrated a consistent, statistically significant improvement in patient-reported pain relief at every week from baseline to week 12, compared to placebo. The most common adverse reactions (>5%) reported by patients with Belbuca in the clinical trials were nausea, constipation, headache, vomiting, fatigue, dizziness, somnolence, diarrhoea, dry mouth, and upper respiratory tract infection.
About Endo International plc
Endo International plc is a global specialty pharmaceutical company focused on improving patients’ lives while creating shareholder value. Endo develops, manufactures, markets and distributes quality branded and generic pharmaceutical products as well as over-the-counter medications though its operating companies. Endo has global headquarters in Dublin, Ireland, and U.S. headquarters in Malvern, PA. Learn more at www.endo.com.