Cephalon drug can have "devastating effects" in noncancer patients

Widening approval for Cephalon Inc's Fentora pain drug to 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 wider U.S. approval to market Fentora, or fentanyl, to treat sudden pain in noncancer patients who have developed a tolerance to opioid drugs. The drug is already approved in the United States for pain flare-ups in cancer patients.

"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.

He added that could also "increase the incidence of accidental exposures which, due to the potency of the product, could potentially have devastating effects".

Rappaport's comments were released ahead of a FDA advisory meeting on Tuesday to discuss the issue with a panel of outside experts.