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news.UCB has received negative opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) regarding Xyrem (sodium oxybate) as a treatment for fibromyalgia syndrome in adults.
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Xyrem is an oral solution that contains the active substance sodium oxybate (500mg/ml). Xyrem is indicated for the treatment of narcolepsy with cataplexy in adults.
UCB said that Xyrem is marketed as a treatment for excessive daytime sleepiness and cataplexy (the sudden loss of muscle tone) in adult patients with narcolepsy by Jazz Pharmaceuticals in US.