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 […]
RESTORE Study of FT218
If you or your child are over 16 and have been diagnosed with narcolepsy, you may qualify for the RESTORE research study. Managing your narcolepsy symptoms is […]
Jazz Pharmaceuticals Announces FDA Approval of Xywav
Jazz Pharmaceuticals plc announced that the US Food and Drug Administration (FDA) approved Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution for the treatment of cataplexy […]
Executive Director Featured on NeurologyLive
At the beginning of March, our Executive Director, Dr. Eveline Honig, participated on a panel that discussed narcolepsy. The panel was assembled by NeurologyLive, a platform that […]
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 […]
Two Clinical Studies on Pitolisant Published
Harmony Biosciences published two clinical studies on WAKIX® (pitolisant). These studies evaluated the long-term safety and efficacy of the medication, as well as its human abuse potential. […]
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 […]