November 13, 2019

FDA Panel Rejects Xyrem as Fibromyalgia Treatment

WebMD reports that the United States Food and Drug Administration has rejected a drug called Xyrem as a treatment for fibromyalgia.  Although public comments (primarily from users testing the drug as part of the manufacturer’s trials) supported approval, and the FDA physicians acknowledge that the drug can reduce pain, the FDA advisory panel rejected the drug because of its similarity to GHB – the so-called “date rape” drug.

According to the FDA, Xyrem, or sodium oxybate, “is much better than the stuff you get on the street, and that is the problem.  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.

Xyrem is currently available for the treatment of narcolepsy.  It is a central nervous system depressant.