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Jazz Pharmaceuticals Announces FDA Acceptance of its New Drug Application for JZP-6 (sodium oxybate) for the Treatment of Fibromyalgia
Date:2/18/2010

o moderate in nature and similar to those seen in previous trials with narcolepsy.  Sodium oxybate has not been evaluated by regulators for the treatment of fibromyalgia and is not approved for this use.

Fibromyalgia is a complex musculoskeletal disorder clinically characterized by widespread pain usually accompanied by fatigue, insomnia, and dyscognition.  According to the American College of Rheumatology (ACR), an estimated 6 million Americans suffer from fibromyalgia.  

About Sodium Oxybate

Sodium oxybate is the sodium salt form of gamma-hydroxybutyrate, 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. Sodium oxybate is the active ingredient in XYREM® (sodium oxybate) oral solution, approved by the FDA and marketed by Jazz Pharmaceuticals in the U.S. for the treatment of excessive daytime sleepiness and cataplexy (the sudden loss of muscle tone) in adult patients 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. Sodium oxybate has not been evaluated by regulators for the treatment of fibromyalgia and is
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SOURCE Jazz Pharmaceuticals, Inc.
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