Orphan Medical Xyrem Planned sNDA Will Aim For First-Line Narcolepsy Claim
This article was originally published in The Pink Sheet Daily
Executive Summary
Phase IIIb trial in excessive daytime sleepiness supports expanding label to include all of narcolepsy, firm says. EXCEEDS data suggest optimal outcomes for Xyrem and Cephalon’s Provigil used together; sNDA planned by year-end.