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FDA Panel Rejects Wider Use Of Painkiller May, 2008





A Food and Drug Administration panel didn't recommend approving expanded use of Cephalon Inc.'s powerful pain reliever Fentora for noncancer patients.

The FDA could decide to approve the drug's use, but it generally follows its panel's advice.

Panel members said at a meeting in Gaithersburg, Md., that they weren't convinced that Fentora does a better job treating noncancer patients with chronic pain than other drugs on the market, despite evidence that 80% of Fentora prescriptions are written for noncancer patients. The panel said it wants Cephalon to compare Fentora with similar painkillers.

"Although we are disappointed, we are not surprised with the results [of the vote]," said Frank Baldino, Cephalon chairman and chief executive, in a conference call. Mr. Baldino called the expansion of Fentora's label a "challenging subject" that comes at a "challenging time" for the agency.

He reiterated sentiments raised last week that the agency remains wary of drugs such as Fentora, because of the issues surrounding OxyContin, a powerful painkiller made by Purdue Pharma LP, and Duragesic, a pain patch made by Johnson & Johnson that was subject to a recall earlier this year following manufacturing issues that could lead to accidental overdoses.

Panel members said they were impressed with a plan Cephalon presented to ensure the drug doesn't fall into the wrong hands. That risk-management plan includes controlling the growth of the drug by restricting the number of physicians who can prescribe it. The plan also would require all shipments of the drug to be connected to radio-frequency identification devices.

Nearly all of the 20 panel members said they would like to see more information from Cephalon about the drug's efficacy, and whether the risk-management plan actually works. For its part, Cephalon urged the panel to support the drug, saying it alleviates pain more quickly than other drugs.

Fentora was approved in 2006 to treat cancer patients suffering from chronic severe pain. Improper dosing and product substitution of the drug has led to deaths. The FDA issued a public-health notice in September 2007 to warn doctors and patients about problems related to the drug. Cephalon has since strengthened Fentora's warnings and improved instructions on the drug's label.

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