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 It was originally developed as an anesthetic, but later withdrawn due to side effects.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.

Continued

"Patients with narcolepsy should receive your highest consideration so that people can rediscover their economic and particularly their family lives and avoid disability," Bob Cloud, who's been taking GHB for years, told the committee.

According to Orphan Medical, studies of GHB in some 400 patients show that the drug reduces daytime sleepiness to the normal range, and at a 9-g dose it cuts the cataplexy rate by two-thirds. Even so, researchers say the drug can cause a variety of mental problems, from depression to suicide attempts to sleepwalking.

Testifying for Orphan Medical, Robert Balster, PhD, of the Medical College of Virginia, told the panel that an "amazing" amount of chemicals that can be made into GHB were already available legally as solvents. Meanwhile, Xyrem, if approved, would be carefully regulated by both federal and state authorities.

In addition, prescriptions would only be available through a closed distribution system through a single pharmacy, and then shipped directly to patients. Still, the critics weren't satisfied.

"We know that users are watching for the release of Xyrem," addiction specialist Deborah Zvorsec, PhD, told the panel. She says some people spend up to $70,000 annually on the illegal version of the drug and would find a pharmaceutical product more desirable.

"This is the most horrid drug I have encountered in my 25 years as a police officer," says Trinka Porrata of her efforts to combat GHB. She says FDA data show 200 deaths caused by the drug.

Panel member Carol Falkowski, PhD, of the Hazelden Foundation warned the FDA advisors that GHB and Xyrem could become another OxyContin, a painkiller that's been widely abused.

Cindy Pekarick testified that an overdose GHB killed her daughter, Nicole, a college student. "She was a loving, caring, sensitive, intelligent woman. Her only fault was that she was naive."

The deadline for FDA action on Xyrem is early July. The agency generally follows the recommendations of its advisory panels, but not always.

WebMD Health News Reviewed by Gary D. Vogin, MD
© 2001 WebMD, Inc. All rights reserved.

Pagination