Cephalon's Nuvigil Test Included "Vacation" in France

Last Updated Jul 1, 2009 1:17 PM EDT

Cephalon will ask the FDA to approve its sleep drug Nuvigil for "Eastbound" jet lag. Not Westbound. Eastbound, the company says.

Why such a strange indication? Turns out Cephalon put 427 adults through what has to be the best clinical trial ever: They flew them from the East Coast of the U.S. to France for a drug-filled vacation observation. Regs chief Lesley Russell told investors:

Subjects were flown from the East Coast of the United States through six hours of time zone changes to arrive in France early in the morning, where they were escorted to a sleep center. Subjects were then given NUVIGIL or placebo once a day for three days. ... Patients taking 150-milligram dose of NUVIGIL showed a statistically significant improvement over placebo.
BNET readers know that this is not the first novel testing method Cephalon has used. You can read about the cocaine-addicted-monkeys chapter of Cepahlon's history here.

Cepahlon's launch of Nuvigil is expected any day now; the drug is expected to replace Provigil which is beset by generic patent challenges. CEO Frank Baldino had this to say about his strategy in his Q1 call:

We're particularly pleased to offer NUVIGIL at a discount to PROVIGIL.
It's the height of chutzpah. The reason Nuvigil will be offered at a "discount" to Provigil is because Cephalon has deliberately raised the price of Provigil in order to make Nuvigil look like a bargain by comparison.

Hat tip to Internet Drug News