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| |  FDA Approves Fentanyl Buccal Soluble Film for Breakthrough Pain ROCKVILLE, Md -- July 16, 2009 -- The US Food and Drug Administration (FDA) has approved fentanyl buccal soluble film (Onsolis) for manage breakthrough pain in certain patients with cancer (>= 18 years) who already use opioid pain medication around the clock and who need and are able to safely use high doses of an additional opioid medicine. Because fentanyl is subject to abuse and misuse, the drug was approved with a Risk Evaluation and Mitigation Strategy (REMS), which is a required plan for managing risks associated with a drug or biological product. "[Fentanyl buccal soluble film] 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, Division of Anesthesia, Analgesia and Rheumatology Products in the FDA's Center for Drug Evaluation and Research, Rockville, Maryland. "For this reason [the drug] should be prescribed only under the safeguards provided by the FDA-required REMS and by health care professionals knowledgeable about [the drug] and the use of potent opioid medications." The FDA Amendments Act of 2007 gave the FDA the authority to require that drugs and biological products have a REMS to ensure that the benefits of a drug or biological product outweigh its risks. As part of the REMS, fentanyl buccal soluble film will only be available through a restricted distribution program called the FOCUS program. Under this program, only those prescribers, patients and pharmacies registered with the program will be able to prescribe, dispense, and receive the drug. The FOCUS program will provide training and educational materials to prescribers and pharmacy personnel, and a counselling call will be placed to patients prior to dispensing to ensure they have been adequately educated about the appropriate use of the drug. Prescription orders will be filled only by participating pharmacies that send the product directly to the patients' homes. Fentanyl buccal soluble film was approved with a boxed warning, which states that the medication should not be used for the management of migraines, dental pain, or postoperative pain or by patients who use opioids intermittently, or on an as-needed basis. SOURCE: US Food and Drug Administration
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