Sleep Disorders (Pediatric)

September 20, 2004

Orphan Medical has announced the results of a phase III b study of Xyrem, for the treatment of excessive daytime sleepiness (EDS) associated with narcolepsy; Xyrem is currently approved for the treatment of cataplexy, another common symptom of narcolepsy. The study found that the study met its primary endpoint of improving wakefulness and alertness, with a significant improvement over placebo in objective wakefulness score, as measured on a standardized scale. Furthermore, the study also met its secondary endpoint of significantly reducing sleepiness score on another, similar objective standardized scale, compared with placebo. The study also found that while Xyrem was effective alone in limiting EDS, co-administration of Provigil (an approved EDS treatment) yielded greater efficacy than either agent alone. The multi-center, double-blind, placebo-controlled, parallel-group study randomized subjects with established EDS into one of four treatment arms for two weeks: Xyrem alone, Provigil alone, Xyrem and Provigil, or placebo. Orphan Medical announced plans to submit an sNDA for Xyrem for the treatment of EDS.