| FDA recommends against ’Modafinil’ |
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Food and Drug Administration (FDA) advisory committee of U.S., on Thursday recommended against Cephalon Inc.’s Modafinil drug saying that the drug is not safe enough to win approval for treating attention deficit hyperactivity disorder (ADHD) in children and teenagers though it is effective against ADHD.
Cephalon Inc.’s Modafinil is being marketed as Provigil for treating sleep disorders. The company is seeking to sell the drug under the name Sparlon for children with ADHD. The ADHD version of the drug, generally known as modafinil, would be a smaller tablet and come in a wider range of doses.
The FDA panel of foreign experts said it was most concerned about a possible link with skin rashes that can lead to hospitalization and recommended that the drug’s manufacturer, Cephalon Inc., conduct a 3,000-patient trial to measure the risk. The drug is as well found in link with aggression, mania and other possible psychiatric effects.
Wayne Goodman, panel chairman and a psychiatrist at the University of Florida said, "I think we’re dealing with some fuzzy information," adding that some more clinical studies are required before the approval. He said, "I don’t want to do that experiment in the post-marketing arena."
Earlier the panel granted the conditional approval for the ADHD use in October 2005, but sought its expert advice over tarriance concerns about the rashes as well as mania, aggression and other possible psychiatric effects.
This is another setback for Cephalon, which has faced obstacles with its experimental sleep disorder drug Nuvigil as well as the Vivitrol alcoholism treatment it is developing with Alkermes Inc.
Thomas Laughren, FDA’s Director of Psychiatry Products said, "They’d have to do a lot more work to show a reason for it to be marketed."
Cephalon Inc. down turned its 2006 sales estimate by $100 million to $1.45 billion to $1.50 billion but is still expecting earnings of $3.80 to $4.00 per share.
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