FDA OKs new painkiller for cancer patients

U.S. health officials approved a new opioid drug to relieve severe flare-ups of pain that occur in cancer patients despite treatment with other pain medications.

The drug, called Onsolis, is made by Aveva Drug Delivery Systems and marketed by Meda AB under a license from BioDelivery Sciences International Inc, the Food and Drug Administration said on Thursday.

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

Onsolis delivers the opioid fentanyl via an absorbable film that sticks to the inside of the cheek, the FDA said.

The drug was cleared for adult cancer patients who already use opioid pain medication around the clock and who need, and can safely use, an additional opioid to treat “breakthrough” flare-ups of pain. Such patients are considered “opioid tolerant.”

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

The FDA said it was requiring safeguards, including distribution limits, to prevent misuse. The drug will only be available through prescribers and pharmacies enrolled in a training program, and the medication will be sent directly to patients’ homes.

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

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* Drug cleared for use in certain cancer pain

* Distribution will be restricted to prevent misuse

WASHINGTON (Reuters)