The U.S. Food and Drug Administration has approved a new opioid drug to treat breakthrough cancer pain.  According to an FDA news release the drug in question, Onsolis delivers the potent medication fentanyl through an absorbable film that adheres to the inside of the user's cheek. 

Made by Aveva Drug Delivery Systems and marketed by Meda AB under a license from BioDelivery Sciences International Inc., Onsolis has been sanctioned for people 18 and older who already use round-the-clock opioid medication to manage pain.

Breakthrough pain occurs when severe flares of pain prove inadequate despite treatment with other pain medications and such patients are considered "opioid tolerant."

For patients who are not opioid tolerant, Onsolis "can lead to overdose, sudden serious breathing difficulties and death," said Bob Rappaport, head of the FDA division that reviewed the drug.

To try to prevent misuse the FDA said it was putting into place safeguards, including distribution limits. Onsolis, approved under the agency's Risk Evaluation and Mitigation Strategy program, requires the drug's maker to submit a plan for managing its risks.  The drug will only be available through registered prescribers and pharmacies enrolled in a training program, and the medication will be sent directly to registered patients' homes.

The drug was approved with the agency's most serious "black-box" label warning, stating that the medication is not meant to remedy pain from migraines, dental problems or procedures, or post-operative pain. The labeling also warns that the drug should be kept out of the reach of children.

Meda and BioDelivery Sciences said they expected the drug would be available in the fourth quarter of 2009.

BioDelivery Sciences said under the terms of its agreement with Meda it would receive about $27 million in milestone payments.

Shares of BioDelivery were up 6.7 percent to $6.40 in afternoon trading on Nasdaq.