Drug To Treat Sleepiness OK'd
Thousands of Americans with narcolepsy, the incurable sleep disorder where patients are awake one minute but napping the next, are getting their first novel treatment in 40 years.
The Food and Drug Administration on Monday approved Cephalon Inc.'s Provigil, a drug to help patients stay awake without the rush and crash of standard stimulants.
Shares of Cephalon, a biotechnology company that primarily treats neurological disorders and cancer, jumped 18 percent Monday.The drug is the first approved for Cephalon in the United States, the company reported. Cephalon's sales people will sell Provigil to sleep centers, sleep specialists, and neurologists.
Shares gained 1 7/16 to 9 5/8.
David Stone of SG Cowen wrote in a research note Monday that the drug could help drive earnings up to 10 cents a share in 2001. The company has yet to turn a profit as a public company and is expected to record a loss of 84 cents a share in its fiscal year 1999.
Stone said the drug is likely to launch at the end of January and estimated the company would tack on $12.5 million in sales for the product in 1999. Cephalon's 1997 sales totaled 23.1 million.
Cephalon tested 550 patients in clinical trials and found Provigil improved patients' narcolepsy symptoms. Side effects in trials included headache, infection, nausea, nervousness, anxiety, and insomnia.
The FDA approved the drug for dosage of 200 mg once a day.
"We've been anxiously awaiting the approval of Provigil," Dr. Merrill M. Mitler, professor at The Scripps Research Institute in La Jolla, Calif. and a Provigil clinical trial investigator, said in a statement. "There has been a real need for an effective (excessive daytime sleepiness) treatment that is well-tolerated."
Provigil is chemically different from amphetamines and other stimulants that narcoleptics now use. While nobody knows if the new drug fights sleepiness as well as stimulants, researchers say Provigil seems safer, with fewer of the troublesome side effects and addictive qualities that frequently make narcoleptics abadon the other treatments.
"This one is unique. ... It's really an exciting new choice," said lead researcher Dr. Joyce Walsleben, director of New York University's sleep disorder center.
Narcolepsy is a debilitating neurological disease afflicting an estimated 125,000 Americans. They suffer irrepressible sleep attacks throughout the day; one minute they're talking or eating, the next they're suddenly asleep. They repeatedly awaken throughout the night.
They also may have cataplexy, muscle weakness that strikes when they're emotional, particularly while laughing, and can cause collapse or sleep paralysis, in which they can't immediately move upon awakening.
Symptoms typically strike during adolescence, but narcolepsy is so regularly misdiagnosed that some people take 15 or 20 years to get help, Walsleben said.
Provigil, known chemically as modafinil, is a once-a-day pill, unlike most narcolepsy stimulants.
Provigil won't hit pharmacy shelves right away. Because it works in the brain, in a region of the hypothalamus that promotes wakefulness, the Drug Enforcement Administration is preparing to classify it a low-level controlled substance. Then Cephalon can ship Provigil.
The company refused to reveal the price, but said it will be less than $10 a pill.
Because Provigil is not an amphetamine, it also is attracting attention as a possible alertness aid for healthy people. Cephalon confirmed it is discussing with the Defense Department testing whether Provigil will help sleep-deprived soldiers stay alert longer.