FDA grants approval of new dosage form for fentanyl

The FDA today announced the approval of Onsolis, a medication that delivers the opioid fentanyl through the mouth’s mucous membranes via an absorbable film that sticks to the inside of the cheek.

The drug is indicated for the management of breakthrough pain in patients with cancer aged 18 or older who already use an opioid pain medication around the clock and who need and are able to safely receive high doses of an additional opioid medicine, according to the FDA.

Because of the potential for abuse and misuse with Onsolis (BioDelivery Sciences Inc. and Meda Pharmaceuticals Inc.), the FDA approved the drug with a Risk Evaluation and Mitigation Strategy, which is a required plan for managing risks associated with a drug or biological product.

As part of this strategy, Onsolis will be available through a restricted program called FOCUS. Only prescribers, patients and pharmacies registered with the program will be able to prescribe, dispense and receive Onsolis. Through the program, the FDA will provide training and educational materials, and counseling calls will be made to patients before dispensing the drug to ensure they have been adequately educated on the appropriate use of Onsolis. Only participating pharmacies that send the product directly to patients’ homes will fill the prescription orders.

Onsolis also carries a boxed warning stating 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. The warning also states that the drug should be kept out of reach of children and should not be substituted for other fentanyl products.

For more information about this approval, visit the FDA website.