In 2011, the European Medicines Agency (EMA) issued an unfavourable opinion on an application for a new indi-cation for sodium oxybate (Xyrem°, UCB Pharma) in idiopathic fibromyalgia, because of an unfavourable harm-benefit balance (a)(1). The EMA considered that the dose-related neuropsychiatric adverse effects of this psychotropic drug observed in clinical trials (including anxiety and depression) were matters of concern, and that the lowest effective dose had not been determined (1). In 2011, an estimated 1 % of the European population suffered from fibromyalgia (2).There is still no effective drug or non-drug treatment for this poorly understood illness (2).
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