Shots: The P-III study involves assessing Xywav vs PBO in patients aged ≥ 7yrs. with cataplexy or EDS with narcolepsy Results: study met its 1EPs & 2EPs i.e. differences in […]readmore
Tags : Cataplexy
Regulatory
Jazz Pharmaceuticals’ Xywav (calcium, magnesium, potassium, and sodium oxybates) Receives
The FDA approval is based on P-III study results assessing Xywav vs PBO in 201 patients to evaluate the safety and efficacy in the treatment of cataplexy and EDS in […]readmore
Shots: The P-III study involves assessing JZP-258 vs PBO in 201 patients with narcolepsy + cataplexy prior treated with Xyrem, naive to Xyrem, or with/without anti-cataplectic treatments The P-III study […]readmore
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 […]readmore