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

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"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
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