FDA panel rejects broader Fentora use

No go, Fentora. An FDA advisory panel voted against broadening the use of Cephalon's painkiller, citing worries that it would in fact be misused. Already the potent drug has caused overdoses and death when it was improperly substituted for another painkiller. Plus, the panel said it could be more attractive to potential abusers because it's stronger than other opioids. The expert advisers told Cephalon to get more data on a proposed risk-management plan for the drug.

The FDA doesn't have to follow the panel's recommendations, but usually does. And an FDA briefing document raised these concerns in advance of the panel meeting. A final decision is expected in mid-September. If the FDA decides to go ahead and approve the expanded label, Fentora could have a potential market of more than 10 million patients, the panel estimated.

After yesterday's meeting, analysts said even if Fentora doesn't get the FDA go-ahead this time around, the drug may still be approved for broader use: It's "a matter of when--not if," one said.

- see Cephalon's release
- see the story in BusinessWeek
- check out the AP article

ALSO: The FDA's decision to reject Merck's new cholesterol med Cordaptive is further proof that the agency is remaining cautious, according to the Star-Ledger. Report

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