WASHINGTON -- The FDA has told Jazz Pharmaceutical it can't approve sodium oxybate (JZP-6), also known as GHB, in its current form for treating fibromyalgia.
The FDA listed a number of reasons for the decision, including the need for additional clinical studies, and the need for methods to ensure its "safe use," according to a company press release.
In August an FDA advisory panel voted 20-2 against approval of the drug for a fibromyalgia indication.
The Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee 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 as Xyrem 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.
http://www.medpagetoday.com/Rheumatology/Fibromyalgia/22668