FDA Panel Considers Narcolepsy Drug
By Randolph E. Schmid
Associated Press Writer
Wednesday, June 6, 2001; 6:53 p.m. EDT WASHINGTON A government advisory panel concluded that a drug abused in date rape can be useful as a treatment for a rare but dangerous complication of the sleep disorder narcolepsy.
The panel convened by the Food and Drug Administration had been asked to consider whether prescription sales should be permitted for GHB gamma hydroxy butyrate under the brand name Xyrem.
The committee voted 6-3 Wednesday that the manufacturer has shown that the drug is useful in treating cataplexy, a complication that can cause people to suddenly collapse when their muscles lose strength.
The vote, in effect, endorses sales of the drug. The FDA is not required to follow the recommendations of its advisory panels, but most often does so.
The advisory panel urged that the FDA if it approves the drug develop a strong risk management plan to make sure that the drug does not get into the wrong hands.
Narcolepsy is marked by recurring episodes of daytime sleep in the victim, lasting from a few seconds to an hour. A new drug, Provigil, was recently approved for that condition, and the committee voted unanimously not to accept Xyrem for general narcolepsy.
Some narcolepsy victims also suffer a cataplexy that can be disabling and dangerous. If approved by FDA, Xyrem would be the first treatment for these people.
GHB, which depresses the central nervous system, originally was developed as an anesthetic. It later was withdrawn because of unwanted side effects. Before 1990, it was available in many health stores but that was halted because of increasing reports of abuse as a recreational drug.
Last year President Clinton signed a bill toughening federal laws for possession and distribution of GHB, which has been linked to at least 58 deaths since 1990 and more than 5,700 recorded overdoses, according to the Drug Enforcement Administration.
It is sometimes used as a date-rape drug. A few drops of the colorless, odorless drug are slipped into a drink. A victim who drinks it can lose consciousness within 20 minutes and often have no memory of what happened. The drug is difficult to trace, often leaving the body within 24 hours.
The law placed GHB in the most strictly regulated category; anyone who makes or distributes it faces a prison term of up to 20 years. The law excepted the clinical studies approved by the FDA to determine whether the drug helps narcolepsy victims.
The cause of narcolepsy has eluded researchers, Stimulant drugs help some victims but can cause side effects. There are about 125,000 narcolepsy patients in the United States. The disease usually strikes in the mid-teens to about age 25 and visits both sexes equally.
Xyrem is made by Orphan Medical Inc. of Minnetonka, Minn.
On the Net:
Food and Drug Administration: http://www.fda.gov
Orphan Medical Inc: http://www.orphan.com/
© Copyright 2001 The Associated Press