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.
The product is expected to be available in the United States by the first quarter of 2016, in seven dosage strengths ranging from 75 μg to 900 μg every 12 hours. "This enables physicians to individualize titration and treatment based on the optimally effective and tolerable dose for each patient," the company statement said.
Approval was based on two double-blind, randomized, placebo-controlled, enriched-enrollment, company-supported phase 3 trials in 1559 patients with moderate to severe chronic low back pain: study BUP-307, which included patients who were opioid experienced, and BUP-308, performed in patients who were opioid naive. Patients had an open-label titration period to a tolerated effective dose and were then randomly assigned to an active or placebo buccal film.
In both studies, the active buccal film provided "consistent, statistically significant improvement in patient-reported pain relief from baseline to week 12, compared to placebo," the company statement said.
The most common adverse reactions (5% or greater) reported by patients receiving active treatment were nausea, constipation, headache, vomiting, fatigue, dizziness, somnolence, diarrhea, dry mouth, and upper respiratory tract infection.
Warnings include the following:
The risk for opioid addiction, abuse, and misuse with the product, which can lead to overdose and death. Physicians should assess each patient's risk before prescribing this product and monitor patients regularly for the development of these behaviors or conditions, the company writes.
The risk for serious, life-threatening or fatal respiratory depression. Physicians should monitor for respiratory depression, especially during initiation of the treatment or after a dose increase, the company said. "Misuse or abuse of Belbuca by chewing, swallowing, snorting, or injecting buprenorphine extracted from the buccal film will result in uncontrolled delivery of buprenorphine and pose a significant risk of overdose or death," the statement adds.
The risk for accidental exposure. "Accidental exposure to even one dose of Belbuca, especially by children, can result in a fatal overdose of buprenorphine."
The risk for neonatal opioid withdrawal. "Prolonged use of Belbuca during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts," the statement said. If prolonged treatment is required in a pregnant woman, "advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available."
The product is contraindicated in patients with significant respiratory depression, acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment, those with known or suspected gastrointestinal obstruction (including paralytic ileus), and hypersensitivity (anaphylaxis) to buprenorphine.
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Cite this: FDA Approval for Buccal Buprenorphine (Belbuca) in Chronic Pain - Medscape - Oct 26, 2015.