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Jazz Pharmaceuticals' JZP-6 to be Reviewed at a Joint Meeting of the FDA's Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee on August 20, 2010
Date:6/24/2010

PALO ALTO, Calif., June 24 /PRNewswire-FirstCall/ -- Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ) announced today that the U.S. Food and Drug Administration's (FDA) 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.

In February 2010, the FDA accepted for filing and review the New Drug Application (NDA) of JZP-6 (sodium oxybate) for the treatment of fibromyalgia.   The target date for the FDA to complete its review of the NDA under the Prescription Drug User Fee Act (PDUFA) is October 11, 2010.  

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 not approved for this use.

About Fibromyalgia


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SOURCE Jazz Pharmaceuticals, Inc.
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