July 17, 2009 — The US Food and Drug Administration (FDA) has approved a fentanyl buccal film (Onsolis, Aveva Drug Delivery Systems under license from BioDelivery Sciences International, Inc) for the management of breakthrough pain in patients with cancer aged 18 years and older who receive around-the-clock opioid therapy and are able to safely use high doses of additional opioid agents.
Because fentanyl is subject to abuse and misuse, the product was approved with a risk evaluation and mitigation strategy that includes a restricted distribution program requiring registration of prescribers, pharmacies, and patients. The program emphasizes the need for clinician and pharmacist education and patient counseling regarding the attendant risks of fentanyl therapy.
"Onsolis can provide strong pain relief to patients who are opioid tolerant. But for patients who are not opioid tolerant, it can lead to overdose, sudden serious breathing difficulties and death," said Bob Rappaport, MD, director, Division of Anesthesia, Analgesia and Rheumatology Products in the FDA's Center for Drug Evaluation and Research, in an agency news release. "For this reason, Onsolis should be prescribed only under the safeguards provided by the FDA-required [risk evaluation and mitigation strategy] and by health care professionals knowledgeable about Onsolis and the use of potent opioid medications."
A boxed warning in the prescribing monograph for fentanyl buccal film advises that the product should not be used for the management of migraines, dental pain, or postoperative pain or in patients who use opioids intermittently on an as-needed basis. The fentanyl buccal film is not interchangeable with other fentanyl products.
Journalist: Yael Waknine (freelance writer for Medscape.)