29 October 2018 - This approval of Xyrem by the FDA marks the first medicine approved to treat cataplexy or excessive daytime sleepiness in children and adolescents with narcolepsy ages seven and older.

Jazz Pharmaceuticals today announced that the U.S. FDA approved its supplemental new drug application on 26 October 2018, to revise labelling for Xyrem (sodium oxybate) oral solution, CIII, to include an indication to treat cataplexy or excessive daytime sleepiness (EDS) in patients with narcolepsy ages seven and older.

The efficacy of Xyrem for the treatment of cataplexy or EDS in paediatric patients with narcolepsy was established in the multisite Phase 2/3 EXPRESS study, which enrolled patients seven to 17 years of age with narcolepsy with cataplexy.

Read Jazz Pharmaceuticals press release