BETHESDA, Md. -- A federal advisory panel voted 20-2 to recommend that the FDA not grant approval for an expanded indication for sodium oxybate (Xyrem) -- also known as GHB -- to treat fibromyalgia.
A number of members on the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committees felt the potential for widespread abuse of the "date rape" drug was too great to warrant expanding the indication to a condition that affects an estimated 2% of the U.S. population.
Sodium oxybate, currently approved at a 500 mg/ml dose for narcolepsy-associated cataplexy and excessive daytime sleepiness, is a central nervous system depressant and carries a boxed warning against its use in combination with other similar drugs.
The label information also warns that sodium oxybate is a drug known to be abused. Sodium oxibate is a sodium salt of y-hydroxybutyrate, or GHB.
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