Tags : Narcolepsy

Jazz Receives FDA Approval for Xyrem’s (sodium oxybate) sNDA to

Shots: 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 […]Read More