FDA to Review Once-Nightly Sodium Oxybate Formulation for Narcolepsy
The NDA submission is supported by data from the phase 3 REST-ON study.
Narcolepsy
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.
FDA Approves Wakix For Excessive Daytime Sleepiness In Adults With Narcolepsy
The Food and Drug Administration (FDA) approved Wakix (pitolisant; Harmony Biosciences) for the treatment of excessive daytime sleepiness (EDS) in adult patients with narcolepsy. Wakix is a first-in-class, selective histamine-3 (H3) receptor antagonist/inverse agonist that works by increasing the synthesis and release of histamine, a wake-promoting neurotransmitter in the brain. It is the first treatment…
New Drug Product: Sunosi
This slideshow reviews drug information for Sunosi. Click here for the complete Sunosi monograph.
Wakefulness Promoter Sunosi Designated Schedule IV Controlled Substance
The Drug Enforcement Agency (DEA) has designated Sunosi (solriamfetol; Jazz Pharmaceuticals) a Schedule IV controlled substance.
