Posted by Michael Wonder on 28 Jun 2018
Jazz Pharmaceuticals announces FDA acceptance of supplemental new drug application for Xyrem (sodium oxybate) to treat cataplexy and excessive daytime sleepiness in paediatric narcolepsy patients
27 June 2018 - Jazz Pharmaceuticals today announced that the U.S. FDA accepted for priority review its supplemental new drug application seeking revised labeling for Xyrem (sodium oxybate) oral solution, CIII, to include an indication to treat cataplexy and excessive daytime sleepiness in paediatric narcolepsy patients.
The Prescription Drug User Fee Act goal date for an FDA decision is 27 October 2018.
With collaboration and a paediatric written request from the FDA, Jazz initiated the global Phase 2/3 EXPRESS study in 2014 to assess the safety, efficacy and pharmacokinetics of Xyrem in paediatric patients, seven to 17 years of age.
