Jazz's Xyrem approved for pediatric narcolepsy with cataplexy

Jazz Pharmaceuticals plc (NASDAQ:JAZZ) said FDA approved an sNDA for Xyrem sodium oxybate to treat cataplexy, or excessive daytime sleepiness, in narcolepsy patients ages seven and older. The drug was previously approved only for adults.

The approval was based on the Phase II/III EXPRESS trial, in which nightly oral Xyrem met the primary endpoint of reducing the weekly number of cataplexy attacks at two weeks vs. placebo in patients ages 7-17 with narcolepsy with cataplexy (see “Jazz’s Xyrem Meets in Phase II/III for Pediatric Narcolepsy with Cataplexy”)...