DUBLIN, Ireland, and RALEIGH, N.C. — Endo Pharmaceuticals Inc. and BioDelivery Sciences International Inc. have gained approval from the Food and Drug Administration for Belbuca buccal film (buprenorphine), an opioid treatment for chronic pain.

Belbuca is the first buprenorphine with a dissolving film absorbed via the inner lining of the cheek.

The companies said Belbuca is the first and only buprenorphine developed with a dissolving film that is absorbed through the inner lining of the cheek for the management of chronic pain. The product is indicated 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.

Plans call for Belbuca to become commercially available in the United States 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 doctors to individualize titration and treatment based on the optimally effective and tolerable dose for each patient.

“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,” stated Rajiv De Silva, president and chief executive officer 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.”

Belbuca is slated to be released early next year in seven dosages.

A mu-opioid receptor partial agonist, Belbuca is a potent analgesic with a long duration of action that uses BioDelivery Sciences’ BioErodible MucoAdhesive (BEMA) technology, which delivers buprenorphine 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, most are on daily doses of 160 mg of oral morphine sulfate equivalent or less, the companies said, and 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 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,” explained Richard Rauck, M.D., director of the Carolinas Pain Institute in Winston Salem, N.C. “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.”