FDA approves Onsolis for cancer patients


ROCKVILLE, Md. The Food and Drug Administration has approved a new drug to treat pain in cancer patients.

The agency approved Miramar, Fla.-based Aveva Drug Delivery Systems’ Onsolis (fentanyl), an opioid medication designed to treat breakthrough pain – pain that “breaks through” regular pain medications – in cancer patients aged 18 and older who need to take an additional opioid medicine and are considered opioid-tolerant.

The drug delivers fentanyl through the mouth’s mucous membranes via an absorbable film that sticks to the inside of the cheek. Because fentanyl is an opioid subject to abuse and misuse, the agency approved Onsolis with a risk-evaluation and mitigation strategy, or REMS, a required plan for managing risks associated with a drug.

“Onsolis can provide strong pain relief to patients who are opioid-tolerant,” FDA Center for Drug Evaluation and Research Division of Anesthesia, Analgesia and Rheumatology Products director Bob Rappaport said in a statement. “But for patients who are not opioid-tolerant, it can lead to overdose, sudden serious breathing difficulties and death.”

Onsolis is a product of BioDelivery Systems in Raleigh, N.C.

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