“Xywav makes it possible for patients to have a lower-sodium oxybate treatment option. The oxybate product contains a unique composition of cations resulting in 92% less sodium, or approximately 1000 to 1500 mg/night, than sodium oxybate (Xyrem Jazz), the only currently approved agent for this indication.
![cataplexy video cataplexy video](http://narcolepsyafricafoundation.org/wp-content/uploads/2018/06/WND-infographic4-750x450.jpg)
In March, the FDA accepted the new drug application (NDA) for JZP-258 for the treatment of cataplexy and excessive daytime sleepiness in those 7 years and older with narcolepsy. Additionally, significant increases in median ESS scores were observed in the placebo group (median, 2.0 ) compared to the treatment group (median, 0 P <.0001). The basis of the approval comes from data showing that the drug demonstrated statistically significant differences ( P <.0001) in the weekly number of cataplexy attacks and Epworth Sleepiness Scale scores compared to placebo in a phase 3 double-blind, placebo-controlled, randomized-withdrawal, multicenter study.ĭuring the double-blind withdrawal period, participants randomized to placebo experienced 2.35 (interquartile range, 0.00 to 11.61) weekly cataplexy attacks compared to 0 (IQR, -0.49 to 1.75) in the JZP-258 group. Jazz Pharmaceuticals has announced that the FDA has approved JZP-258 (Xywav) oral solution for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age or older with narcolepsy.