Jazz Pharmaceuticals Inc, Palo Alto, Calif, submitted a New Drug Application to the US Food and Drug Administration (FDA) for JZP-6 (sodium oxybate oral solution) for the treatment of fibromyalgia. Sodium oxybate is the active ingredient in XYREM, which is approved by the FDA and marketed by Jazz Pharmaceuticals in the United States for the treatment of excessive daytime sleepiness and cataplexy in adult patients with narcolepsy.
According to the company, results from two Phase III clinical trials show sodium oxybate significantly decreased pain and fatigue as well as improved daily function, patient global impression of change, and sleep quality in patients with fibromyalgia.
Currently, sodium oxybate has not been evaluated by regulators for the treatment of fibromyalgia and is not approved for this use.
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