FDA Panel Rejects Xyrem as Fibromyalgia Treatment

An FDA advisory panel today overwhelmingly rejected the application of Jazz Pharmaceuticals for the approval sodium oxybate (Xyrem) for the treatment of fibromyalgia.

The drug is chemically similar to GHB, widely considered a date-rape drug. Approving it for such a large patient population -- 5 million people are estimated to suffer from fibromyalgia -- would risk flooding the streets with a pharmaceutical-grade version of the highly controlled substance.

"Sodium oxybate and GHB are the same thing," said panelist Lewis Nelson, MD, of the New York University School of Medicine. "This is much better than the stuff you get on the street, and that is the problem."

Currently, the drug is only approved for the treatment of narcolepsy. It has been prescribed for 35,000 people since it was introduced in 2002.