Jazz Pharmaceuticals, Inc. has announced that the FDA's Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee will review JZP-6 (sodium oxybate) for the treatment of fibromyalgia at a joint meeting on August 20, 2010. The target date for the FDA to complete its review of the New Drug Application is October 11, 2010.
If approved, sodium oxybate would be the fourth drug to receive approval for the treatment of fibromyalgia. Sodium oxybate is the active ingredient in Xyrem® oral solution, currently approved for the treatment of excessive daytime sleepiness and cataplexy (the sudden loss of muscle tone) in adult patients with narcolepsy.
Sodium oxybate is the sodium salt form of gamma-hydroxybutyrate (GHP), an endogenous neurotransmitter and metabolite of GABA. While the precise mechanism of action is unknown, the effects may be mediated in part through interaction with GABA(B) and GHB receptors.
Xyrem is classified as a schedule III drug and its distribution is restricted through the Xyrem Success Program. It can only be purchased from a central, mail-order pharmacy. Patients receiving Xyrem are first required to read a letter and brochure as well as watch a video about the medication. The reason for the restrictions on Xyrem is because of its potential for abuse – GHB has been used as a date-rape drug.
The request for approval of sodium oxybate as a treatment for fibromyalgia was based on the results from two Phase III clinical trials. In both trials, sodium oxybate significantly decreased pain and fatigue as well as improved daily function, patient global impression of change, and sleep quality. You can read more details of the studies here:
First Phase III Clinical Trial
Second Phase III Clinical Trial
In the studies, sodium oxybate was generally well tolerated, with the majority of adverse events reported being mild to moderate in nature and similar to those seen in previous trials with narcolepsy. The most commonly reported adverse drug reactions in narcolepsy patients are dizziness, nausea and headaches. Sodium oxybate has the potential to induce respiratory depression and neuropsychiatric events.
Jazz Pharmaceutical Press Release. June 24, 2010.
Published On: June 29, 2010