Positive Results from IH Phase 3 Study of Xywav
Jazz Pharmaceuticals plc announced positive top-line results from their Phase 3 double-blind, multicenter, placebo-controlled, randomized withdrawal study evaluating the efficacy and safety of an investigational use of […]
FDA Approved the Expanded Use Of WAKIX® (pitolisant) for the Treatment of Cataplexy
Harmony Biosciences Holdings, Inc. (“Harmony”) announced that the US Food and Drug Administration (FDA) has approved WAKIX® (pitolisant) for the treatment of cataplexy in adult patients with […]
Videos of Your Cataplexy
Do you have videos of what your cataplexy looks like and would be willing to share? Marilyn Swick and Dr. Todd Swick have been working in sleep […]
New Narcolepsy Study
The Sparkle 1501 Study for Narcolepsy Further development is needed in treating narcolepsy, a sleep disorder that disrupts the brain’s ability to regulate sleep-wake cycles, causing persistent […]
Avadel Completes the REST-ON Phase 3 Trial of FT218
Avadel Pharmaceuticals plc, who is developing FT218, an investigational, once-nightly formulation of sodium oxybate for the treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy, […]
Jazz Pharmaceuticals Announce the FDA Acceptance of New Drug Application for JZP-258
Jazz Pharmaceuticals plc announced that the US Food and Drug Administration (FDA) accepted for filing with Priority Review the company’s New Drug Application seeking marketing approval for […]
Axsome Therapeutics Announces AXS-12 Achieves Primary Endpoint in CONCERT Phase 2 Trial in Narcolepsy
Axsome Therapeutics, Inc. announced that AXS-12 (reboxetine) met the prespecified primary endpoint and significantly reduced the number of cataplexy attacks as compared to placebo in patients with […]
Avadel Pharmaceuticals Achieves Enrollment Target in REST-ON Phase 3 Pivotal Trial of FT218
Avadel Pharmaceuticals announced that it has achieved its patient enrollment target of 205 patients in the REST-ON Phase 3 clinical trial for FT218, an investigational, once-nightly formulation […]
Jazz Pharmaceuticals Presents Positive JZP-258 Phase 3 Study Data at World Sleep 2019
Jazz Pharmaceuticals plc announced positive data from the Phase 3 study of its investigational medicine, JZP-258, for the treatment of cataplexy and excessive daytime sleepiness in adults […]