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FDA Approves Belbuca (buprenorphine) Patch

October 27, 2015
A new buccal film patch, designed to fit flexibly on the inner cheek, has been approved by the US Food and Drug Administration as a long-acting Schedule III opioid therapy for chronic pain patients.

Belbuca (buprenorphine), a new film formulation of buprenorphine that is placed on the inner cheek, has recently been approved by the US Food and Drug Administration. The drug is intended for patients that require around-the-clock, daily, long-term pain management, for which other treatment options are inadequate, noted a press release from the manufacturer Endo Pharmaceuticals Inc.

Belbuca is expected to be made commercially available by the first quarter of 2016. It is being marketed for both opioid-naïve and opioid-experienced patients, and will come in 7 dosage strengths, ranging from 75 μg to 900 μg, given every 12 hours. The company noted that doctors can individualize their treatment and titration options using the drug.

Developed by Endo Pharmaceuticals Inc., a subsidiary of Endo International, and BioDelivery Sciences International, Inc., Belbuca is the first treatment of its kind, utilizing a novel buccal film delivery system designed for convenience and flexibility, while providing the efficacy and vetted safety profile of a competent buprenorphine treatment.

"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, MD, the Director of Carolina’s Pain Institute, in Winston Salem, North Carolina.

Belbuca functions as a potent analgesic, a mu-opioid receptor partial agonist that has a unique delivery system. Patients administer the patch to the inside lining of their cheek, the buccal mucosa, which delivers the drug in long-acting fashion.

Safety Profile

Buprenorphine is considered a Schedule III controlled substance, having a reported lower abuse potential than most other opioids, which typically have a Schedule II classification. Because many chronic pain patients typically take daily regimens of opioid dosages around 160 milligrams of oral morphine sulfate equivalent (MSE), Belbuca features a similar range, with its 7 dosage ranges increasing up to 160 mg MSE.

However, like other long-action opioid formulations, Belbuca does carry similar risks of misuse, abuse, addiction, and overdose death. Because of this, Belbuca is intended for patients that cannot tolerate or receive benefit from non-opioid analgesics or immediate-release opioids. Belbuca is not intended as an as-needed analgesic.

The drug was given FDA approval after the conclusion of two double-blind, randomized, placebo-controlled, enriched-enrollment Phase 3 studies, in which 1,559 opioid-experienced (study BUP-307) and opioid-naïve (study BUP-308) patients were assessed to see how well Belbuca provided pain management to their moderate to severe chronic low back pain, compared to placebo. During an open-label period, the patients were titrated properly to a tolerated dose of the drug, before they were randomized to either continue taking the drug or a placebo.

Both studies showed that opioid-experienced and opioid-naïve patients had statistically significant improvements in their patient-reported pain relief at every week up to week 12 of the study, compared to placebo. Out of the 1,559 patients studied, ≥ 5% experienced common adverse reactions, including 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, the President and CEO of BioDelivery Sciences International, Inc.

Last updated on: December 1, 2015
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