FDA Concerned Expanded Fentora Approval Could Increase AbuseMay 5, 2008 | Parker Waichman LLP
The US Food and Drug Administration (FDA) has long been concerned over Cephalon Inc.’s marketing of Fentora, a cancer pain drug, to non-cancer patients. An FDA official said Fentora use in noncancer patients could have "devastating effects. Cephalon continues to seek FDA approval to promote Fentora—fentanyl buccal—for sudden pain in noncancer patients with an opioid tolerance.
Last September, Cephalon submitted a request to the FDA seeking approval to market Fentora for breakthrough pain management in opioid-tolerant noncancer patients. Given that Cephalon’s illegal marketing practices have been under constant scrutiny in recent years and the FDA issued a pubic warning over Fentora following reports its use led to breathing problems, deaths, and other serious complications, this was an odd request.
"We are concerned that the sponsor's request to expand the current indication for Fentora ... may greatly increase the prescribing of this product which may increase the availability of the product for diversion, abuse, and misuse," wrote Bob Rappaport, head of the FDA's Division of Anesthesia, Analgesia, and Rheumatology Products. Rappaport added Fentora could "increase the incidence of accidental exposures which, due to the potency of the product, could potentially have devastating effects."
In 2006, the Wall Street Journal investigated Cephalon’s marketing of Actiq—Cephalon's other fentanyl drug sold in a lollipop form—and discovered 80 percent of patients prescribed Actiq were not cancer patients and Cephalon frequently focused marketing of Actiq to noncancer physicians in sports medicine and family practice specialties. That same year, the Connecticut Attorney General discovered Cephalon illegally marketed Actiq for off-label use and set high sales quotas that could only be met through off-label dispensing. Cephalon’s marketing of Fentora had also been under investigation by the US Attorney in Philadelphia as well as by Congress. Actiq has been linked to over 120 deaths. In the case of Fentora, illegal marketing has been linked to four deaths, none of which occurred in cancer patients. Cephalon admitted some of these deaths were due to off-label use.
Fentora and Actiq are FDA-approved only for use in cancer patients for break-through pain—pain that occurs quickly, is severe, and is of short duration. Fentora is contraindicated for noncancer-related pains and for cancer patients intolerant to or not undergoing constant opioid therapy; the drug is indicated for a very specific population, is a faster acting version of Actiq, and is not a generic version of any opioid-containing drug. Because Fentora is dosed to deliver higher amounts of fentanyl—a highly addictive opiate 80 times more powerful than morphine—it is never to be substituted for any other drug since misuse at any dose can—and has—resulted in death.
The FDA is conducting an advisory meeting tomorrow with a panel of external experts regarding whether wider Fentora use should be approved. The FDA said it received reports Fentora was incorrectly prescribed, given at wrong doses, and that tablets were inappropriately substituted by doctors and pharmacists for Actiq. Cephalon told reporters, "There is no evidence that Fentora poses risks of abuse and diversion greater than other opioids." Cephalon said it expects the FDA to make its final decision by September 13.