• 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 patients with narcolepsy
• The study resulted in statistically significant differences in weekly number of cataplexy attack and Epworth Sleepiness Scale scores
• Xywav- also known as JZP-258 is targeted for the treatment of cataplexy or excessive daytime sleepiness in patients 7 years of age and older with narcolepsy. Additionally- the USDEA has designated Xywav as a Schedule III medicine also contains a boxed warning of as a central nervous system depressant

­ Ref: Jazz Pharmaceuticals | Image: Jazz Pharmaceuticals