Opioid Pain Reliever Onsolis Earns FDA Approval

Onsolis, a potent pain reliever meant for cancer patients who suffer from intense flare ups of pain which cannot be controlled by regular pain medication, has been approved by the Food and Drug Administration.

The drug belongs to a class of drugs that deliver opioid fentanyl through mucous membranes in the mouth using an absorbable film that sticks to the inside of the cheek. It is approved for cancer patients ages 18 and older who already use opioid pain medication and can safely tolerate a higher dose of additional opiod pain drug for so-called “breakthrough pain.”

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., the FDA said.

Restrictions on Access to Onsolis

Because of its potency, Onsolis is subject to abuse and misuse, especially in patients who are not tolerant of opioids, the FDA said. Therefore, it should only be prescribed according to a Risk Evaluation and Mitigation Strategy (REMS) accompanying its approval and by physicians who are experienced and knowledgeable with opioid medications.

According to the REMS for Onsolis, access to the drug will be restricted and available only to prescribers, patients, and pharmacies who register with the program. Other restrictions on how Onsolis is prescribed and delivered to patients also will be in place to prevent abuse, misuse, and accidental overdoses, the FDA said.

Onsolis also will carry a so-called “Black Box” warning on the product’s packaging stating it should not be used for treating migraines, dental pain, or pain following surgery by patients who do not frequently use opioid medications, the FDA said.

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