Trial of Possible New Fibromyalgia Drug to Move Forward

NEWSBRIEF: Jazz Pharmaceuticals, Inc. says it has completed enrollment in the second of 2 Phase III clinical trials of JZP-6 (sodium oxybate) as a fibromyalgia treatment.

Jazz expects to file a New Drug Application with the U.S. FDA by the end of 2009. That would mean the FDA would be likely to make a decision on it in 2010 or 2011.

Sodium oxybate is the active ingredient in Xyrem, which some people already take for fibromyalgia. Clinical trials have shown that it can significantly improve sleep quality and reduce fibromyalgia pain. This drug depresses the central nervous system (generally believed to by hyper-responsive in fibromyalgia), and researchers believe this improves sleep-stages 3 and 4. Many doctors believe that better sleep is vital to improving fibromyalgia symptoms.

Currently, Xyrem is approved for excessive daytime sleepiness and sudden loss of muscle tone in adults with narcolepsy. Because of its potential for abuse, Xyrem is a Schedule III federally controlled substance.

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