FDA approves Onsolis for pain relief

WASHINGTON, July 16 (UPI) -- The U.S. Food and Drug Administration has approved the drug Onsolis, an opioid medication intended for use by cancer patients to help manage severe pain.

"Onsolis is in a class of drugs that deliver the potent opioid fentanyl through the mouth's mucous membranes," the FDA said in a statement. "Onsolis delivers fentanyl 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, ages 18 and older, 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."

The drug will be only be available through a restricted distribution program in which only prescribers, patients and pharmacies registered with the program will be able to prescribe, dispense and receive Onsolis, the FDA said.

Onsolis is manufactured by Aveva Drug Delivery Systems of Miramar, Fla.