Serdexmethylphenidate Gets Orphan Drug Status for Idiopathic Hypersomnia
Serdexmethylphenidate is a proprietary prodrug of d-methylphenidate.
Diagnosis & Disease Information
Oral Orexin Agonist Gets Breakthrough Therapy Status for Narcolepsy Type 1
The Company is currently investigating TAK-994 in adults with narcolepsy type 1 or type 2 in a phase 2 study.
Xywav Gets Priority Review for Idiopathic Hypersomnia
The sNDA is supported by data from a phase 3 study that assessed Xywav in adults with idiopathic hypersomnia.
FDA to Review Once-Nightly Sodium Oxybate Formulation for Narcolepsy
The NDA submission is supported by data from the phase 3 REST-ON study.
Wakix Indication Expanded to Include Cataplexy Treatment
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.
Idiopathic Hypersomnia Study Evaluating Xywav Meets End Points
The multicenter, double-blind, placebo-controlled phase 3 study evaluated the efficacy and safety of Xywav in adults with idiopathic hypersomnia.
FDA Approves Xywav for Narcolepsy
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.
Clinical Improvement Observed in Narcolepsy Trial Evaluating Once-Nightly Sodium Oxybate Formulation
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.
Lower Sodium Oxybate Formulation Gets Priority Review for 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.
Relationship Between Vaccination and Neurologic Diseases Multifaceted
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.
