Wider use of Cephalon drug opposed
A Food and Drug Administration official said in documents yesterday that allowing Cephalon Inc. to sell its Fentora pain drug more widely for patients without cancer could lead to potentially fatal abuse.
A Food and Drug Administration official said in documents yesterday that allowing Cephalon Inc. to sell its Fentora pain drug more widely for patients without cancer could lead to potentially fatal abuse.
Fentora, a potent narcotic pain medicine, is now approved only to treat pain flare-ups in cancer patients. Cephalon, of Frazer, is seeking regulatory approval to sell Fentora, also known as fentanyl buccal, for sudden pain bouts in non-cancer patients.
An FDA advisory panel will meet Tuesday to discuss the expanded use. Cephalon expects the FDA to make a final decision by Sept. 13.
FDA staff concluded that the risks of an "unintentional potentially fatal overdose," as well as of misuse and abuse, are "extremely high" and raise "serious safety concerns," an FDA document said.
Cephalon shares closed yesterday at $60.58, down $2.78, or 4.4 percent, from the previous day's close.
Last September, the FDA issued a public warning letter for Fentora after reports that it had been linked to several deaths as well as respiratory problems and other serious side effects.
The drug has been prescribed "off label" to treat ailments such as migraine headaches, sports injuries and back pain. The FDA has said that it is dangerous to use Fentora to treat short-term pain such as migraines, and that Fentora should be used only by patients who take opioids regularly and have developed a tolerance to narcotic pain medicines.
While doctors are free to prescribe medicines for any condition they think appropriate, drug manufacturers can promote products in the United States only for uses approved by the FDA.
Bob Rappaport, head of the FDA's Division of Anesthesia, Analgesia and Rheumatology Products, said in documents yesterday that approving Fentora for wider use might greatly increase "the availability of the product for diversion, abuse and misuse."
Rappaport's comments were released ahead of the FDA advisory meeting Tuesday. The FDA will ask the panel whether wider use should be approved. The FDA will make a final decision later.
Unprocessed fentanyl is a highly addictive substance 80 times more potent than morphine. Fentanyl is regulated as a Schedule II substance by the Drug Enforcement Agency and is in the same category as cocaine and methamphetamine, with the highest potential for abuse and risk of fatal overdose. Fentora was approved by the FDA in September 2006.
Read briefing documents (.pdfs) issued by Cephalon and by the FDA on Fentora at