The agency is concerned that the powerful Fentora pain drug will be easily abused if made available on a widespread basis. Right now, the Cephalon lozenge is used to treat pain associated with acute pain suffered by cancer patients, but the drugmaker wants FDA approval to sell the narcotic to treat sudden pain in others.
Last September, the FDA issued an advisory linking Fentora to four deaths, and Cephalon blamed inappropriate prescribing for such ailments as back pain. The drugmaker, however, denied off-label marketing activities, which came under investigation by the US attorney in Philadelphia, the Connecticut attorney general, and a congressional committee. But next Tuesday, an FDA advisory committee will meet to review Cephalon's request for wider approval.
"We are concerned that the sponsor’s request to expand the current indication...may greatly increase the prescribing of this product which may increase the availability of the product for diversion, abuse and misuse, and increase the incidence of accidental exposures which, due to the potency of the product, could potentially have devastating effects," wrote Bob Rappaport, head of the FDA's division of Anesthesia, Analgesia and Rheumatology in briefing documents.
If the agency did allow Fentora to be marketed to non-cancer patients with chronic pain, Cephalon would have to develop a risk management plan to mitigate abuse, he added. In its own briefing documents, has "extensive experience" in managing narcotic abuse, including its Fentora tablets.