Cephalon drug gets FDA panel review
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Medical experts will consider Tuesday whether use of a painkiller made by Cephalon Inc. should be expanded, despite government concerns about increased risks for abuse.Cephalon’s drug Fentora is already approved to treat severe pain flare-ups in cancer patients taking opioids, a type of prescription painkiller. On Tuesday the FDA will ask a panel of outside experts whether it should be approved to treat pain in non-cancer patients, a larger market that includes those suffering from back and nerve pain.

But the FDA said in documents released last week that wider approval could have “devastating effects,” including wider abuse and misuse of the drug. The agency is not required to follow the recommendation of its panelists, though it often does.

The FDA has received reports of doctors prescribing Fentora “off-label,” or for uses that have not been cleared as safe and effective. Like other types of opioid drugs, Fentora can be addictive and has been abused for its euphoric effects.

Cephalon has reported five patient deaths connected with misuse of the drug.

Analysts are split on Cephalon’s chances for expanding the market for Fentora, which accounted for 8 percent of total company sales last year.

On Friday, Lehman Brothers analyst Jim Birchenough lowered his price target for Cephalon to $88 from $93, saying the FDA’s comments were more negative than he expected. He wrote that the FDA could actually decide to restrict, rather than expand use of the drug.

But Banc of America Securities analyst Steven Lichtman said the FDA documents look good for Cephalon, and predicted that the agency will ultimately approve an expanded label, paving the way for greater sales.

admin @ 11:39 am

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