Date-Rape Drug OKd to Treat Sleep Disorder

WASHINGTON —  A drug implicated in date rapes and nightclub deaths won federal approval Wednesday for treating a rare type of sleeping disorder, under special restrictions aimed at stopping its diversion to nonmedical uses.

GHB, or gamma hydroxybutyrate, has an unusual four-decade history of use as an anesthetic, a body-building supplement and a party drug popular on the rave scene. But reports of deaths and seizures among users and the drug’s ability to incapacitate rape victims prompted Congress in 2000 to toughen laws for its possession and distribution.

The drug was sometimes manufactured at home, and it was linked to at least 58 deaths and 5,700 overdoses between 1990 and 2000. The Food and Drug Administration banned its marketing in 1990 and barred all chemical analogues a decade later.

On Wednesday, however, the FDA approved the drug for use by individuals with cataplexy, a sudden loss of muscle tone that can cause a person to collapse. Cataplexy affects an estimated 50,000 of the 120,000 or so people with narcolepsy, a sleep disorder.

FDA officials said they had worked with the Drug Enforcement Administration and the drug’s manufacturer, Orphan Medical Inc. of Minnetonka, Minn., to design strict restrictions on the distribution of GHB.

Patients will be able to obtain the drug only through a single pharmacy, which will keep a master list of people receiving it and doctors prescribing it. The list, the drug company and the FDA said, will allow the pharmacy to detect whether patients are refilling prescriptions too quickly or are obtaining prescriptions from several doctors--both indications of possible misuse of the drug.

“The physician will receive a phone call after every prescription to validate the prescription,” said Dr. William Houghton, executive vice president for scientific affairs at Orphan Medical. Patients must also tell the pharmacy by phone that they have read an educational packet that explains the dangers of misuse and the correct way to dispose of unused medication.

“This is about as restrictive an approval that I’ve been a part of,” said Dr. Russell Katz, chief of the FDA’s neurological drugs division. “No system is 100% fail-safe. Things can happen, of course. But we thought this was a system that for the most part will ensure a minimum to no diversion, and hopefully safe use of the drug.”

The drug will be sold under the name Xyrem.

Restrictions on the sale of a medicine are unusual, but not unique. Patients cannot obtain the anti-psychotic drug clozapine without showing the results of a blood test, Katz said. The requirement is aimed at preventing a life-threatening decrease in white blood cells. And when RU-486, the “abortion pill,” came to market in 2000, the manufacturer said it would distribute the medication through doctors, not pharmacists.

An advisory panel of the FDA had ruled previously that GHB was effective in treating cataplexy, but split on whether it was safe to market, Katz said.

He said final approval was granted in part because cataplexy is a “devastating condition” and because there is no other approved treatment for it.

Usually triggered by strong emotional states, such as laughter or sadness, cataplexy causes a loss of muscle tone that can range in severity, causing eyelids to droop, speech to slur or knees to buckle. Patients are conscious during the episode, but they are unable to move certain muscles.

The condition is one symptom of narcolepsy, a disease characterized by an irresistible tendency to fall asleep, even during a conversation or a meal.