January 30, 2007
Medication for narcolepsy sufferers in Europe has taken a step forward with the recent recommendation that Xyrem®, indicated in Europe for the treatment of cataplexy in adult patients with narcolepsy, be granted marketing authorization by the European Commission.
The recommendation came from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA). According to a press release from the maker of the drug, UCB, Brussels, Belgium, the European Commission is expected to issue a decision within approximately 6 weeks.
“This positive opinion is encouraging news, and we now look forward to the opportunity of making Xyrem available to more patients in Europe with this sleep disorder,” said Troy Cox, president CNS Operations, UCB. “With this expanded indication, Xyrem would be the first and only medicine approved by the European Medicines Agency for the treatment of narcolepsy with cataplexy in adult patients.”
Xyrem is indicated in Europe for the treatment of cataplexy in adult patients with narcolepsy. Sodium oxybate, the active ingredient in Xyrem, is a sodium salt of gamma- hydroxybutyrate.
The most commonly reported adverse drug reactions are dizziness, nausea, and headache, all occurring in 10% to 20% of patients. Sodium oxybate is contraindicated in patients with succinic semialdehyde dehydrogenase deficiency. Sodium oxybate is contraindicated in patients being treated with opiods or barbiturates.