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Jazz Pharmaceuticals announces submission of JZP-6 NDA for treatment of fibromyalgia

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Category: Medical Info and Drug Trials

Published on Thursday, 17 December 2009 12:31

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Jazz Pharmaceuticals, Inc. announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for JZP-6 (sodium oxybate oral solution) for the treatment of fibromyalgia.

The submission is based on their clinical development program for JZP-6, including results from two Phase III clinical trials. In these trials (you can read our previous coverage here), sodium oxybate significantly decreased pain and fatigue as well as improved daily function and sleep quality. Sodium oxybate has not been evaluated by regulators for the treatment of fibromyalgia and is not approved for this use.

The full press release can be found here.

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(R), 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 American Academy of Sleep Medicine recommends sodium oxybate as a standard of care for the FDA-approved indications. UCB markets XYREM(R) (sodium oxybate oral solution) in Europe, where it is approved by the EMEA for the treatment of narcolepsy with cataplexy in adult patients under a license from Jazz Pharmaceuticals. 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.