Serdexmethylphenidate Gets Orphan Drug Status for Idiopathic Hypersomnia
Serdexmethylphenidate is a proprietary prodrug of d-methylphenidate.
Serdexmethylphenidate is a proprietary prodrug of d-methylphenidate.
The Company is currently investigating TAK-994 in adults with narcolepsy type 1 or type 2 in a phase 2 study.
The sNDA is supported by data from a phase 3 study that assessed Xywav in adults with idiopathic hypersomnia.
The NDA submission is supported by data from the phase 3 REST-ON study.
The approval was based on data from two phase 3 trials (HARMONY CTP and HARMONY 1) that evaluated the efficacy and safety of pitolisant for the treatment of cataplexy.
The multicenter, double-blind, placebo-controlled phase 3 study evaluated the efficacy and safety of Xywav in adults with idiopathic hypersomnia.
The FDA has approved Xywav™ (calcium, magnesium, potassium, and sodium oxybates; Jazz Pharmaceuticals) oral solution for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients aged ≥7 years with narcolepsy.
Positive topline data from the phase 3 REST-ON trial evaluating FT218 (Avadel), an investigational, once-nightly formulation of sodium oxybate, showed that the treatment led to clinically meaningful improvement in patients with narcolepsy.
The FDA has accepted for Priority Review the New Drug Application (NDA) for JZP-258 (Jazz Pharmaceuticals) for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients aged ≥7 years with narcolepsy.
Researchers highlighted the need for rapid investigations of vaccine safety concerns to use robust epidemiologic methods to maintain public and professional confidence in vaccination programs.