- The approval is based on P-II/III EXPRESS study assessing Xyrem vs PBO in patients with narcolepsy with cataplexy aged 7-17 yrs.
- P-II/III EXPRESS study results: @2 wks. change in weekly number of cataplexy attacks, change in EDS; @47 wks. increment in weekly cataplexy attacks (0.3 vs 12.7); no new safety signals observed published in the Lancet Child & Adolescent Health 2018
- to Micromedex DRUGDEX monograph, Xyrem (CIIA) is recommended for cataplexy in narcolepsy in the pediatric patient and also a novel FDA approved PO (CIII) drug for pediatric patients (7 yrs) & adults indicated for cataplexy and excessive daytime sleepiness in narcolepsy
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