A drug for jet lag? Feds put Cephalon's Nuvigil on the fast-track for approval

Jet lag is a drag. There's no better way to put it. Melatonin, warm baths, herbal teas and meditation are all supposed "cures," but no really agrees on whether they really work. A transatlantic or transpacific flight can turn even the fittest among us into zombies for days. Now comes news from biopharmaceutical Cephalon (CEPH) that federal regulators have put the first potential prescription drug for jet lag "disorder" on the fast-track for approval.

The drug showed in trials that 427 people who took 150 milligrams of Nuvigil after traveling from the United States to Europe experienced a "statistically significant improvement" in sleep over those who only took a dummy pill, the company said in its first-quarter earnings conference call. But Kevin Kedra, an analyst with Gabelli & Company in Rye, New York, says that Cephalon is ultimately looking at additional indications for Nuvigil, including potentially treating bipolar depression. "There is sort of a bigger end market for the company," says Kedra. "Jet lag is sort of the first step."
Drug companies often seek approval from the U.S. Food and Drug Administration for multiple indications once a drug has been deemed to be safe. Nuvigil is actually a newer version of Cephalon's Provigil -- or the generic modafinil -- which is used to treat excessive sleepiness from obstructive sleep apnea, narcolepsy and other sleep disorders, Kedra says. Sales of Frazer, Pennsylvania-based Cephalon's Provigil approached $1 billion in 2008, according to the Associated Press.

There is currently no FDA-approved treatment for jet lag disorder, Cephalon says. The company says in its statement that it expects approval from the agency for treating jet lag disorder due to eastbound travel by December 29. No word yet if, and when, the drug will also be approved for westbound travel -- and how the drug's use in travel in the opposite direction could actually be monitored.

In its current indications, Nuvigil does carry a warning for serious or life-threatening rash that has been reported in adults and children taking modafinil, the company says. It is not approved for children in any indication. As far as the jet-lag trials go, the company says that the most common side-effects in the clinical studies were headaches, nausea, dizziness and insomnia. Insomnia? It just goes to show that there may still be no great substitute for plain old sleep.
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