WASHINGTON (Reuters) - Allowing Cephalon Inc to market its Fentora pain drug more widely for patients without cancer could have "devastating effects," a U.S. Food and Drug Administration official said in documents released on Friday.
By Susan Heavey
WASHINGTON (Reuters) - Allowing Cephalon Inc to market its Fentora pain drug more widely for patients without cancer could have "devastating effects," a U.S. Food and Drug Administration official said in documents released on Friday.
The company is seeking the FDA's approval to promote Fentora, or fentanyl, for sudden pain in non-cancer patients who have developed a tolerance to opioids. The drug is already approved in the United States for pain flare-ups in cancer patients.
The FDA's pending review of the new use has already been weighing on Cephalon shares, which fell more than 3 percent following the FDA's comments.
!ADVERTISEMENT!"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 that could also "increase the incidence of accidental exposures which, due to the potency of the product, could potentially have devastating effects."
Narcotic drugs, including opioids such as Fentora, are highly addictive and sought out for their calming effects. Even patients with pain can become dependent and abuse them.
Rappaport's comments were released ahead of an FDA advisory meeting on Tuesday to discuss the issue with a panel of outside experts. The agency is set to ask the panel whether wider use should be approved, according to the documents, although the FDA will make the final decision later.
Last September, the FDA issued a pubic warning over Fentora following reports that its use has led to deaths as well as breathing problems and other serious complications.
In Friday's documents, the FDA said it had also received reports that Fentora was being incorrectly prescribed and given at wrong doses. The tablets were also inappropriately substituted by doctors and pharmacists for Actiq, Cephalon's other fentanyl drug sold in a lollipop-like form on a stick.
Cephalon, in a statement to reporters, said "there is no evidence that Fentora poses risks of abuse and diversion greater than other opioids."
Analysts said the FDA's concerns were not surprising given known problems with narcotics.
Megan Murphy, a senior analyst at Lazard Capital Markets, wrote in a research note that Cephalon officials appeared to have lowered their expectations ahead of the FDA meeting. "We remain cautious regarding the outcome of the panel and the product's potential in the broader non-cancer population," she said.
If the FDA does allow Fentora to be marketed to non-cancer patients with chronic pain, Cephalon would have to have a plan in place to try to mitigate abuse, Rappaport said. But he pointed to doubts over whether risk management programs for potent opioid drugs have been successful.
In a separate document also released on Friday, the company cited its "extensive experience" in managing narcotic abuse and said it had further developed tools to monitor Fentora.
Cephalon's efforts to curb abuse with the wider approval largely include plans to further educate prescribers, according to the document. It also vowed not to begin marketing the new indication beyond the 4 percent of doctors it said are already experienced with Fentora.
About 800,000 U.S. doctors are allowed to prescribe such opioid drugs by the U.S. Drug Enforcement Administration, according to a company spokeswoman.
Cephalon said it expects the FDA to make its final decision by September 13.
Shares of Cephalon were down 3.7 percent at $61.03 in morning trade on Nasdaq.
(Reporting by Susan Heavey, editing by Gerald E. McCormick and Dave Zimmerman)
