ORPHAN MEDICAL SUBMITS XYREM sNDA

Orphan Medical has submitted a supplemental new drug application (sNDA) for Xyrem oral solution to the FDA.

Xyrem (sodium oxybate) is currently marketed as the first and only approved treatment for cataplexy, a sudden loss of muscle tone that is a debilitating symptom of narcolepsy.

The sNDA is expected to expand the Xyrem label to encompass improvement in the other primary symptoms of narcolepsy, specifically the reduction of excessive daytime sleepiness and the improvement in fragmented nighttime sleep, in addition to the established efficacy of Xyrem in treating cataplexy.