It was recently announced that the EMA has rejected Xyrem for the treatment of fibromyalgia. Interestingly, Xyrem is already approved in Europe for the treatment of narcolepsy with cataplexy.
We have written about the many unmet needs in fibromyalgia previously. Surprisingly, no drug is approved in Europe for fibromyalgia. This is rather unfortunate, as fibromyalgia, in our view, is a very real, chronic, debilitating disease.