DATE-RAPE DRUG SET TO TREAT AILMENT

WASHINGTON - The notorious date-rape drug GHB won government approval
Wednesday to treat a rare but dangerous complication of the sleep disorder
narcolepsy.

It will be sold under some of the most severe restrictions ever imposed on
a medicine.

The Food and Drug Administration approval carves out one medical use for an
otherwise illegal chemical.

Throughout the 1990s, the government had cracked down on illegal GHB use a
" abused as a party drug, sex and athletic enhancer and, because it can
knock people out, a date-rape drug.

Several dozen deaths are blamed on the chemical. But GHB was hard to stop
because it was easy for people to make.

Now the maker of the only FDA-approved version, Orphan Medical Inc., will
have to balance how to get GHB to the relatively few patients it could help
while keeping it from falling into the wrong hands.

"No system, I believe, is foolproof, but there will be very close tabs"
kept on every GHB shipment, said Dr. Russell Katz, FDA's neurologic drugs
chief.

Narcolepsy is marked by recurring episodes in which patients suddenly fall
asleep from a few seconds to an hour.

GHB doesn't treat that symptom. However, anywhere from 20,000 to 50,000
narcolepsy patients also suffer from cataplexy, a muscle-weakness
complication that can cause people to collapse without warning.

Orphan Medical's version of GHB, to be sold under the brand name Xyrem,
marks the first FDA-approved treatment for cataplexy. Studies suggest Xyrem
(pronounced Zy-rem) could reduce cataplexy attacks by up to 70 percent.

Originally developed as a surgical anesthetic, GHB was pulled off the
market because of side effects: it depresses breathing and can cause coma,
even kill.

Then in 1990, some companies began selling it as a dietary supplement, and
use as a recreational drug took off. Colorless and odorless, it made
headlines when people slipped it into drinks, knocking out victims who
often had no memory of what happened.

By the mid-'90s, the government had declared any GHB use outside of
FDA-sanctioned clinical trials illegal. A 2000 law toughened penalties so
abusers or distributors could face a prison term.

Consequently, cataplexy patients who want to use Xyrem face a host of
restrictions.

Every doctor who prescribes Xyrem must enroll on an FDA-monitored registry
that also will record the name and medical progress of every patient who
takes it.

Orphan Medical will hire one pharmacy to distribute Xyrem, sending it by
Fed-Ex to the homes of properly registered patients who have certified they
understand how to use it and the penalties for abuse.

The patient must sign for each shipment and reports of lost or missing
pills will immediately trigger an investigation.

Orphan Medical said it will begin sales by year's end but did not release a
price.