Xyrem rejected for Fibromyalgia in EU
European regulators have this week rejected the medication Xyrem (sodium oxybate) as a treatment for Fibromyalgia Syndrome (Fibro).
Belgian pharmaceutical firm, UCB, which in-licensed the drug from Jazz Pharmaceuticals, currently markets Xyrem (sodium oxybate) in the European Union for the treatment of narcolepsy with cataplexy. UCB announced on March 17th that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has informed UCB that Xyrem will not be recommended as a treatment for fibromyalgia syndrome in adults.
Prof Iris Loew-Friedrich, Chief Medical Officer at UCB said:
"Upon discussions and following oral explanation with the CHMP, we have to accept that Xyrem® in fibromyalgia syndrome will not be recommended for approval in the EU near-term."
Prof Loew-Friedrich went on to add that:
"We are very disappointed with the CHMP decision given the significant unmet medical need in fibromyalgia syndrome in Europe today and the consistently positive phase 3 clinical trials with Xyrem® in the indication."
No medication has yet been granted EU marketing approval as specific treatments for Fibro. Xyrem is the fourth medication to be refused EU marketing approval as a treatment for Fibro, with Lyrica (Pregabalin), Cymbalta (Duloxetine) and Savella (Milnacipran) already having been rejected.
Lyrica, Cymbalta and Savella are approved by the American Food and Drug Administration (FDA) for the treatment of Fibro, but Xyrem was refused FDA approval in October 2010.
All of these medications are however approved in Europe for other indications, which means that doctors can prescribe them for their patients with Fibro if they consider that they are appropriate.