'Club Drug' approved by FDA for cataplexy in narcoleptic patients. (Prescribing Highly Restricted).
The drug, sodium oxybate or [gamma]-hydroxybutyrate (GHB), is a central nervous system depressant. Approval for this indication was based on two 4-week studies of almost 200 patients with narcolepsy; most of the patients were also on CNS stimulants.
In one study, patients on 6 g or 9 g per day of sodium oxybate had 10 and 16 fewer attacks per week, respectively, compared with 4 fewer attacks per week with placebo.
The exact mechanism of action on cataplexy is unknown, but it appears to involve improved nighttime sleep. Side effects in trials included confusion, nausea and vomiting, and bedwetting.
Orphan Medical of Minnetonka, Minn., will market the drug under the trade name Xyrem.
GHB was widely available and marketed as a dietary supplement for various claims in health food stores until 1990, when the FDA prohibited its marketing after reports of abuse-related respiratory arrests and deaths.
Since then, GHB has been abused as a recreational drug and has resulted in serious sequelae, including fatalities. It also became known as one of the "date rape drugs.
Because of these problems, the drug was approved with a comprehensive risk management program to limit distribution. The program includes patient and physician registries and availability from a centralized pharmacy.
All patients using the drug will receive a medication guide with information about the drug's proper use, administration, and disposal.
Xyrem has been designated a schedule III drug and cannot be sold, distributed, or provided to any one for any reason other than its approved use.
Cataplectic attacks may affect as many as 25,000 of the estimated 135,000 U.S. narcolepsy patients, according to experts.
A copy of the medication guide and other information on the drug and the risk management program are available at www.fda.gov/cder/drug/infopage/xyrem/default.htm.
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|Publication:||Clinical Psychiatry News|
|Date:||Oct 1, 2002|
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