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Cephalon jet lag application rejected

Cephalon has dropped its bid to get sleep disorder drug Nuvigil approved as a treatment for jet lag after a second rejection from the US FDA

Cephalon has dropped its bid to get its sleep disorder drug Nuvigil (armodafinil) approved as a treatment for jet lag after the marketing application was rejected by the US Food and Drug Administration for the second time.

The company said it has received a Complete Response Letter from the FDA stating that the agency does not feel that the concerns raised in a similar letter issued in March were sufficiently addressed to allow approval of the drug for the new use.

The FDA's concerns revolve around what the agency feels is a lack of robustness in the data gathered from a Patient Global Impression of Severity measurement. Cephalon stressed that Nuvigil met the primary endpoints of pivotal studies comparing the drug to placebo.

"Cephalon believes we met the agreed upon safety and efficacy endpoints… However, following several conversations with the agency, and given this second complete response letter, the company believes that further communications with the FDA will not result in an approval of this application," said Dr. Lesley Russell, Chief Medical Officer at Cephalon. "As a result, the company is no longer pursuing this indication."

Nuvigil, a next-generation, longer-acting version of Cephalon's Provigil (modafinil), is approved in the US to treat wakefulness in patients with excessive sleepiness associated with treated obstructive sleep apnea, shift work disorder and narcolepsy.  Cephalon has been seeking a new approval for the drug as a treatment for excessive sleepiness associated with jet lag resulting from eastbound travel.

Currently, there are no prescription drugs specifically approved by the FDA for jet lag, although doctors prescribe various drugs off-label for the use. Cephalon has been working to gain new approvals for Nuvigil as part of its efforts to get patients to shift to the newer drug from Provigil, which will face generic competition beginning next year. Nuvigil is on patent until 2024.

4th January 2011

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