Jazz Pharmaceuticals’ Xywav (calcium, magnesium, potassium, and sodium oxybates) Receives the US FDA’s Approval for Cataplexy or Excessive Daytime Sleepiness Associated with Narcolepsy

 Jazz Pharmaceuticals’ Xywav (calcium, magnesium, potassium, and sodium oxybates) Receives the US FDA’s Approval for Cataplexy or Excessive Daytime Sleepiness Associated with Narcolepsy

PharmaMar and Jazz Receive the US FDA’s Priority Review Acceptance of Lurbinectedin’s NDA for Patients with Relapsed Small Cell Lung Cancer

  • 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

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