Endo launches Belbuca (buprenorphine) buccal film for chronic pain management

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

Belbuca was approved by FDA in October 2015 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. The FDA approval was based on data from two placebo-controlled, randomized Phase 3 studies showing that Belbuca provided significant improvement in patient-reported pain relief with a low incidence of typical opioid-like side effects.

"We are pleased to announce the commercial availability of Belbuca in the US. In preparation for launch, Endo has committed significant resources to provide physicians and patients with broad access to this important, new chronic-pain medicine," said Rajiv De Silva, President and CEO of Endo. "The launch of Belbuca builds on Endo's legacy of leadership in pain and exemplifies our focus on enhancing therapeutic options for patients and healthcare providers in this arena. It also demonstrates our capacity and commitment to successfully bring new treatments to market — from clinical development to commercialization."

Belbuca is available in seven dosage strengths for flexible dosing from 75 μg to 900 μg every 12 hours, allowing physicians to titrate Belbuca individually for patients to a tolerable dose that provides adequate analgesia with minimal side effects.

"Belbuca broadens the options for healthcare professionals and patients living with pain who require around-the-clock opioid treatment and for whom alternative treatment options are inadequate," said Richard L. Rauck, President of Carolinas Pain Institute, Winston Salem, NC. "Belbuca offers the proven efficacy and safety of buprenorphine with buccal film technology for improved absorption of buprenorphine, which may help reduce the potential for misuse and potentially lessen the incidence of certain side effects."

Belbuca is a mu-opioid receptor partial agonist and a potent analgesic with a long duration of action that utilizes patented BioErodible MucoAdhesive (BEMA) drug delivery technology from BioDelivery Sciences International. 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 oral MSE, Belbuca offers a treatment choice for a wide range of opioid needs in chronic pain sufferers.