FDA Approval for Buccal Buprenorphine (Belbuca) in Chronic Pain

U.S. FDA Approves BELBUCA™ (buprenorphine) Buccal Film for Chronic Pain Management

 

FDA has approved buprenorphine (Belbuca, Endo Pharmaceuticals) buccal film for use in patients with chronic pain.

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Belbuca is the first and only buprenorphine available as a dissolving film that is absorbed through the inner lining of the cheek for chronic pain management. The drug is a mu-opioid receptor partial agonist and a potent analgesic with a long duration of action that utilizes BioDelivery Sciences International, Inc. (BDSI’s) patented BioErodible MucoAdhesive (BEMA) drug delivery technology, which allows the drug to be efficiently delivered across the buccal mucosa. It is indicated for use in patients with chronic pain severe enough to require daily, around-the-clock, long-term opioid treatment and for whom alternative treatment options are inadequate.

FDA has approved buprenorphine (Belbuca, Endo Pharmaceuticals) buccal film for use in patients with chronic pain.

The US Food and Drug Administration (FDA) has approved a buprenorphine buccal film product (Belbuca, Endo Pharmaceuticals) for the treatment of chronic pain severe enough to require daily, around-the-clock, long-term opioid treatment, for whom alternative treatment options are inadequate, the company has announced.

The product is the first such formulation to combine buprenorphine, approved already for pain management, with a buccal film delivery system, the company notes. Buprenorphine is a Schedule III controlled substance, meaning it is viewed as having lower abuse potential than Schedule II drugs that include most opioids. The dissolving film is absorbed through the inner lining of the cheek.

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.

The US Food and Drug Administration (FDA) has approved a buprenorphine buccal film product (Belbuca, Endo Pharmaceuticals) for the treatment of chronic pain severe enough to require daily, around-the-clock, long-term opioid treatment, for whom alternative treatment options are inadequate, the company has announced.

Buprenorphine is a Schedule III controlled substance, meaning that it has been defined as having lower abuse potential than most opioid analgesics, which are classified as Schedule II. The medication will be available in 7 dosage strengths up to 160 mg of oral morphine sulfate equivalent, allowing physicians to individualize titration and treatment based on the 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-naive 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.”

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 every week from baseline to Week 12 vs. placebo for both studies.

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.

 

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