Nuvigil is a slight modification of Provigil, an older stimulant that will face generic competition in 2012. Provigil sales were about $1 billion in 2008, accounting for half of Cephalon’s revenue. Nuvigil, which first went on sale in June and has a longer patent life, had sales of $38 million through September.
The F.D.A., to the surprise of even Cephalon, agreed to review the Nuvigil application in six months, instead of the usual 10. Such a priority review is usually granted to drugs for serious diseases, though the agency says it can also give rapid reviews to the first drug for a less serious ailment.
But in late December, the agency delayed its decision until March 29, to allow more time to analyze the data, according to Cephalon. The agency does not comment on drugs under review.
Jet lag results when the body’s internal clock is out of sync with daily life, making people sleepy when they want to be awake and wakeful when they want to sleep. It is one of several so-called circadian rhythm disorders that are attracting increasing attention from the pharmaceutical industry. Some studies suggest that disruption of the daily rhythms can contribute to obesity, mental illness and other ailments.
Nuvigil and its predecessor, Provigil, are already approved to treat the excessive sleepiness associated with narcolepsy, sleep apnea and “shift work sleep disorder” — which can affect people who work the graveyard shift. But the drugs are prescribed widely to treat the sleepiness associated with other diseases, or even just to help healthy people get by on less sleep.
For jet lag, Nuvigil would be approved to treat only the sleepiness associated with jet lag disorder — not to shift the body’s clock to the new time zone.
“It’s something that can help you overcome the symptoms, but not the cause of the problem,” said Charmane I. Eastman, director of the biological rhythms research laboratory at Rush University Medical Center in Chicago, who was not involved in Cephalon’s trial.
Cephalon plans to aim Nuvigil at business travelers who might go to Europe for a couple of days, not those staying longer term. For a short trip, “you don’t want to shift your circadian clock very much,” said Dr. Lesley Russell, Cephalon’s chief medical officer.
The company’s executives are not predicting how much an approval for jet lag would add to Nuvigil sales. The drug would be taken for only a day or two to treat jet lag, whereas other uses involve taking it for long periods.
A market challenge for Cephalon will be that Nuvigil costs at least $9 a pill, with one pill usually taken each day. Nuvigil will have to compete with inexpensive jet-lag treatments like coffee, sleeping pills and the nutritional supplement melatonin.
Nuvigil has not been clinically compared with those remedies, some of which might work as well but have never been specifically approved for jet lag. Sleeping pills, for example, are approved to treat insomnia, whatever the cause, so there has been no need to seek a specific approval for jet lag, said Thomas Roth, director of the sleep disorders and research center at Henry Ford Hospital in Detroit and a consultant to Cephalon.
And stimulants like caffeine and amphetamines, he said, are generic, so manufacturers have no incentive to conduct clinical trials.
But even if Nuvigil sales for jet lag are small, F.D.A. approval would help Cephalon advance its franchise-extending strategy.
But Provigil will face generic competition in April 2012 under terms of an agreement Cephalon made with several generic drug manufacturers. The Federal Trade Commission has sued Cephalon, saying it paid off those generic manufacturers to delay the advent of competition.
Cephalon, which denies the charges, is trying to shift patients from Provigil, also known as modafinil, to the very similar but slightly longer-acting Nuvigil, or armodafinil. Nuvigil has patent protection until 2024, although generic drug companies are already moving to challenge those patents.
To get patients to shift, Cephalon has raised the wholesale price of Provigil to $13.60, from about $5.50 a pill five years ago, including a 29 percent increase in November. So Provigil is now 50 percent more expensive than Nuvigil.
And Cephalon is also trying to have Nuvigil approved for new uses beyond those of Provigil.