Onsolis Approved for Cancer Patient Pain Relief

Onsolis approved as cancer pain relief

Onsolis was approved by the FDA today. The medication is intended for cancer patients to help manage breakthrough pain (severe flares of pain that break through regularly scheduled pain medication).

Onsolis is in a class of drugs that deliver the potent opioid fentanyl through the mouth’s mucous membranes. Onsolis uses an absorbable film to deliver fentanyl. The absorbable film sticks to the inside of the cheek.

The FDA approved the use of Onsolis for use in cancer patients, ages 18 and older, who need breakthrough pain management. It is intended for those who are already on opioid pain medication around the clock.


The active ingredient in Onsolis is fentanyl. Fentanyl has been known to be abused and misused. Therefore, the FDA has given approval with a Risk Evaluation and Mitigation Strategy, or REMS, attached.

The REMS requires a plan for managing risks associated with the drug. For Onsolis, part of the REMS is a restricted distribution program called the FOCUS program. Only those prescribers, patients and pharmacies registered with the program will be able to prescribe, dispense, and receive Onsolis. The FOCUS program provides training and educational materials to prescribers and pharmacy personnel. Patients will receive a counseling call prior to dispensing to ensure they have been adequately educated.

A boxed warning on Onsolis 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. There is also a warning that the drug should be kept out of the reach of children and should not be substituted for other fentanyl products.

Onsolis is manufactured by Aveva Drug Delivery Systems, Miramar, Fla., and marketed under license from BioDelivery Sciences International Inc. of Raleigh, N.C., by Meda Pharmaceuticals Inc., based in Somerset, N.J.

FDA News Release