Xyrem (sodium oxybate) oral solution, CIII, is indicated to treat cataplexy in narcolepsy and for the treatment of excessive daytime sleepiness (EDS) in narcolepsy.
The drug is the only FDA approved treatment for narcolepsy with cataplexy in adults and the approval was based on clinical data in primarily adult patients.
Around 100 pediatric patients globally at sites in the US and several countries in Europe will be enrolled in the 52-week, randomized, double-blind, open-label, multicenter Phase III Xyrem Pediatric Narcolepsy trial.
In three controlled clinical trials, the most common adverse reactions in Xyrem-treated patients were nausea, dizziness, vomiting, somnolence, enuresis and tremor.