Buccal buprenorphine approved for patients with chronic pain

October 27, 2015

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

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.

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.

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 “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,” said Dr. Mark A. Sirgo, President and CEO of BDSI, in a press release. 

FDA's approval of Belbuca was based on 2 phase 3 studies in which a total of 1,559 opioid-experienced and opioid-naïve patients suffering from chronic low-back pain received the study drug. The trials included an open-label period in which patients were titrated to a tolerated and effective dose of Belbuca and then randomized to either continue on the medication or receive a placebo buccal film. In both studies, Belbuca demonstrate a consistent, statistically significant improvement in patient-reported pain relief at every week from baseline to week 12, compared to placebo.

Some of the most common adverse reactions associated with the use of Belbuca in the clinical trials included nausea, constipation, headache, vomiting, fatigue, and dizziness. Because of the risks of addiction, abuse, and misuse with opioids, and because of the risks of overdose and death in long-acting opioid formulations, Belbuca should be reserved for use in patient for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.

Belbuca is expected to be available in the United States during the first quarter of 2016.

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