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FDA gets application for new Fibromyalgia drug

Thursday 17 December 2009

Jazz Pharmaceuticals's Adrienne Dellwo reports on a potential new drug for Fibromyalgia:

Jazz Pharmaceuticals, Inc. says it has submitted a New Drug Application to the FDA for JZP-6 (sodium oxybate) as a fibromyalgia treatment.

Sodium oxybate is the active ingredient in the drug Xyrem, which currently is on the market for narcolepsy. Many people take it off label for fibromyalgia.

Jazz says the application includes results from two Phase III clinical trials showing the drug significantly decreased pain and fatigue, and improved both daily function and sleep quality.

• Learn more about JZP-6 (Sodium Oxybate)

The above originally appeared here.


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