FDA Approves Drug for Narcolepsy, but Market May Grow
The Food and Drug Administration has approved a novel drug that keeps people with debilitating sleepiness awake and attentive yet has few of the side effects associated with caffeine, amphetamines and other commonly used stimulants.
The drug, modafinil, was approved by the FDA for people with a serious sleep disorder called narcolepsy, which affects 1 out of 1,000 to 2,000 people and is characterized by sudden, overwhelming waves of intense sleepiness.
It will be available only by prescription, under the brand name Provigil and marketed by Cephalon Inc. The compound will be listed by the Drug Enforcement Administration as a Schedule IV substance, which means it will be regulated more tightly than most prescription drugs.
Despite those restrictions, several experts said they would not be surprised if the pills quickly gained popularity among many of the millions of people who suffer from daytime sleepiness caused by problems more mundane than narcolepsy, such as overwork and stress-related insomnia.
The drug may also find a “gray market” following among truck drivers, emergency room doctors, soldiers in battle, college students and others whose jobs demand that they remain awake for days. Preliminary studies on Canadian soldiers found that modafinil increased wakefulness and vigilance in subjects who went without sleep for three days, without the agitation or “rebound” fatigue that typically follows long stretches of amphetamine-induced wakefulness.
The most common side effects seen in studies included headache, nausea, nervousness and insomnia, the company, Cephalon, said.
Doctors who are licensed to prescribe DEA-scheduled drugs may prescribe them to people who do not have the disorder for which they were approved. But physicians who do so must be able to justify to federal officials their reasoning for writing such “off-label” prescriptions.
Experts said only time would tell whether doctors will feel comfortable prescribing modafinil to non-narcoleptics. If the DEA determines that the drug is being overprescribed or abused, the agency can increase restrictions.
Analysts at BancBoston forecast that the drug will have sales of about $6 million next year, growing to $26 million in 2001, based only on its use for narcolepsy.
The company announced modafinil’s approval Monday, after getting word from the FDA on Dec. 24. Its stock jumped 12%, rising $1 to close at $9.19 on Nasdaq.
Frank Baldino, president of West Chester, Pa.-based Cephalon, emphasized that the drug has been proven safe and effective only for narcoleptics.
But he acknowledged that the company is pursuing research to test the drug’s usefulness for other sleep-related disorders, including apnea, a nighttime breathing disorder that disrupts sleep in an estimated 12 million Americans.
The drug is expected to become available in February.
