UCB's Xyrem gets CHMP recommendation

Belgian biopharmaceutical company UCB says that the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use has issued a positive opinion recommending the approval of the narcolepsy drug Xyrem (sodium oxybate). Specifically, the CHMP has advised that the product is granted marketing approval for use in the treatment of the condition in adults who suffer from cataplexy.

Narcolepsy is a debilitating long-term disorder that is characterized by daytime tiredness, and is most prevalent between the ages of 20 and 30. The condition is usually associated with disturbed night-time sleep, cataplexy (the sudden loss of muscle tone), sleep paralysis and hypnagogic hallucinations.

UCB explained that the agent, which was granted Orphan Drug designation for the narcoleptic indications by the EMEA in February 2003 (Marketletters passim), has demonstrated its efficacy in three multicenter, double-blind, placebo-controlled studies. The firm added that a 12-month extension trial also showed that long-term use of the product was safe.