FDA Panel Says Yes to Date-Rape Drug for Sleep Disorder

From the WebMD Archives

June 6, 2001 (Bethesda, Md.) -- An FDA advisory panel has recommended approval for a pharmaceutical form of GHB, a notorious drug of abuse, as a limited treatment for a dangerous complication of narcolepsy. Also known as sodium oxybate or gamma hydroxybutyrate, the chemical is apparently valuable in controlling some of the worst symptoms of narcolepsy, a relatively rare condition marked by repeated bouts of daytime sleepiness.

GHB has been implicated in many so-called date rapes, and the substance can cause a variety of reactions, from intoxication, sedation, and euphoria to coma and death. Members of the FDA's Peripheral and Central Nervous System Drugs Advisory Committee want to be sure that the pharmaceutical version, named Xyrem, is only available under tight restrictions.

In a mixed decision, the committee voted to require extensive safeguards before the product can be used. If approved, the FDA might attempt to restrict its use to narcolepsy only.

"We already know that we've got to work with the FDA through some of those safety issues. ... Our clinical trials showed that at therapeutic doses, the drug works," says John Howell Bullion, CEO of the drug's maker, Orphan Medical Inc., of Minnetonka, Minn. Bullion says no additional uses of Xyrem are being studied at this time.

Despite its fairly new reputation as a club drug, GHB has been studied as a medical treatment for some 30 years. It was originally developed as an anesthetic, but later withdrawn due to side effects.

Those who argued in favor of using the chemical to treat narcolepsy pointed out that the 125,000 Americans suffering from the condition often suffer nightmarish hallucinations at night and often fail to get a normal, restful sleep. A subset of patients is also affected by a complication called cataplexy -- an onset of generalized muscular weakness that causes them to suddenly collapse.

The committee agreed that Xyrem, a liquid, works against cataplexy but not against the daytime sleepiness. In fact, the FDA statistician told the advisors that there was "negative evidence" GHB had an impact on daytime sleepiness.

Although stimulants and antidepressants are used as treatments for this life-altering disease, advocates say better therapy is needed. Xyrem, in spite of having a sedative effect, may help keep people awake during the day by giving them a better night's sleep.

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