Fentora’s expanded label nixed by FDA panel

WASHINGTON A Food and Drug Administration panel voted against broadening the label for Cephalon’s pain drug Fentora, according to the Associated Press.

The drug is approved to treat breakthrough pain in cancer patients. The company is looking for the drug to be approved to treat sudden pain bouts in non-cancer patients.

The panel voted yesterday 17 to 3 against expanding the label, but the panel’s tone was said to be positive, which could give Cephalon an opportunity to win FDA approval for the expanded label.

While the panel could have recommended outright rejection for the request, it recommended further study instead. Cephalon has already started a trial comparing Fentora to an instant-release form of the drug oxycodone.

Cephalon expects the FDA to make a final decision by Sept. 13.