4 May 2018 - - Dublin, Ireland-based international biopharmaceutical company Jazz Pharmaceuticals plc (NASDAQ: JAZZ) has filed a supplemental new drug application (sNDA) with the US Food and Drug Administration seeking revised labeling for Xyrem (sodium oxybate) oral solution, CIII, to include an indication to treat cataplexy and EDS in pediatric narcolepsy patients,.
Xyrem, the sodium salt of gamma hydroxybutyrate (GHB) is a central nervous system depressant.
Xyrem is indicated for the treatment of cataplexy in narcolepsy and for the treatment of excessive daytime sleepiness in narcolepsy. Xyrem may only be dispensed to patients enrolled in the Xyrem REMS Program.
The current US package insert for Xyrem indicates that safety and effectiveness in pediatric patients have not been established.
Jazz Pharmaceuticals is focused on improving patients' lives by identifying, developing and commercializing meaningful products that address unmet medical needs.
The company has a diverse portfolio of products and product candidates with a focus in the areas of sleep and hematology/oncology.