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.
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A Drug Enforcement Administration rule will require pharmacies dispensing products containing gamma hydroxybutyrate such as Xyrem to compile the names of the prescribing practicioner. Xyrem is distributed through a single pharmacy.
Orphan Medical Xyrem Central Pharmacy Will List Prescribers Under DEA Rule
A Drug Enforcement Administration rule will require pharmacies dispensing products containing gamma hydroxybutyrate such as Xyrem to compile the names of the prescribing practicioner. Xyrem is distributed through a single pharmacy.
Orphan Medical Xyrem Scripts Average 500 Per Week For Last Six Weeks
Firm hopes positive Phase IIIb data from excessive daytime sleepiness trial will boost script numbers ahead of sNDA filing in second half of year. SXB-15 trial shows statistically significant results for primary and secondary endpoints.