Onsolis Approved for Breakthrough Pain

Onsolis (fentanyl buccal soluble film) has been approved by the U.S. Food and Drug Administration for the treatment of breakthrough cancer pain.[1]

Pain may be a side effect of cancer treatment or may be caused by the cancer itself. If not adequately managed, pain may have a tremendous effect on quality of life. Many cancer patients with chronic pain receive treatment with an opioid; however, they continue to experience flares of pain referred to as breakthrough pain. Breakthrough pain can become intensely painful within a few minutes, yet an opioid can take up to 30-60 minutes to take effect.

Onsolis delivers a potent opioid drug called fentanyl through an absorbable film that adheres to the inside of a patient’s cheek. The drug is designed to target pain more quickly. It is currently indicated for the treatment of cancer patients over the age of 18 who have developed a tolerance to opioid therapy.

Onsolis is subject to abuse and was approved with a Risk Evaluation and Mitigation Strategy (REMS), which is a required plan for managing risks associated with a drug. The medication comes with a serious warning label indicating that it is not appropriate for pain associated with migraines, dental pain, or postoperative pain. It is strictly indicated for patients who are experiencing breakthrough pain while receiving opioid therapy.

Onsolis will only be available through a restricted distribution program called the FOCUS program, in which only registered prescribers and pharmacies will be able to prescribe the drug. Registered patients will be able to receive the drug after a counseling call to educate them about the drug; the drug will then be sent directly to their home.


[1] FDA News Release. July 16, 2009. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm172366.htm.

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