FDA approves BELBUCA (buprenorphine) buccal film for chronic pain management

Endo Pharmaceuticals Inc., a subsidiary of Endo International plc, and BioDelivery Sciences International, Inc., has announced 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 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, M.D., Director of Carolinas Pain Institute, Winston Salem, NC. "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. For both opioid-naïve and opioid-experienced patients who require around-the-clock treatment and for whom alternative treatment options are inadequate, BELBUCA™ offers appropriate, consistent pain relief and a low incidence of typical opioid-like side effects."

BELBUCA™ is a mu-opioid receptor partial agonist and a potent analgesic with a long duration of action that utilizes BDSI's patented BioErodible MucoAdhesive (BEMA®) drug delivery technology. Through this unique delivery system, buprenorphine is efficiently and conveniently delivered across the buccal mucosa (inside lining of the cheek). Buprenorphine is a Schedule III controlled substance, meaning that it has been defined as having lower abuse potential than Schedule II drugs, a category that includes most opioid analgesics. Among chronic pain patients taking opioids, the vast majority are on daily doses of 160 mg of oral morphine sulfate equivalent (MSE) or less. With seven dosage strengths up to 160 mg MSE, BELBUCA™ offers a treatment choice for a wide range of opioid needs in chronic pain sufferers.

"The FDA approval of BELBUCA™ represents an important and meaningful milestone for Endo Pharmaceuticals, demonstrating our strength in bringing a valuable new therapy from pipeline through approval. Our advancement of BELBUCA™ also underscores Endo's long-standing heritage of innovation and its commitment to supporting the pain community," said Rajiv De Silva, President and CEO of Endo. "We are proud to add BELBUCA™ to our diversified portfolio of branded and generic products and we look forward to preparing for the expected U.S. launch of the drug in early 2016."

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-naïve (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, diarrhea, dry mouth, and upper respiratory tract infection.

"We are excited about the FDA approval of BELBUCA™ as we believe it is a testament to the strength of BDSI's partnership with Endo, and our ability to combine our expertise and resources to advance the available options in the treatment of chronic pain," said Dr. Mark A. Sirgo, President and CEO of BDSI. "BELBUCA™ is uniquely formulated with our BEMA® drug delivery technology that allows for high bioavailability of buprenorphine in the bloodstream, and represents an important new option for patients and healthcare providers."

About BELBUCA™

BELBUCA™ (buprenorphine) buccal film is indicated 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.

Limitations of Use

Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with long-acting opioid formulations, reserve BELBUCA™ for use in patients for whom alternative treatment options (eg, non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. BELBUCA™ is not indicated as an as-needed (prn) analgesic.

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