Axsome Therapeutics, Inc. has announced that AXS-12 (reboxetine), a highly selective and potent norepinephrine reuptake inhibitor and cortical dopamine modulator, achieved the primary endpoint and significantly reduced the frequency of cataplexy attacks as compared to placebo in patients with narcolepsy in the SYMPHONY Phase 3 trial. AXS-12 also reduced excessive […]
Pharmacological
First Global Phase 3 Trials of Narcolepsy Type 1 Oral Orexin Agonist
Takeda has announced positive topline results from a randomized, double-blind, placebo-controlled, multiple-dose Phase 2b trial evaluating TAK-861, an oral orexin receptor 2 (OX2R) agonist, in patients with narcolepsy type 1. Narcolepsy is a chronic, rare neurological disorder of central hypersomnolence with significant unmet need despite multiple approved therapies. It is […]
Apnea Pill: First Patient Dosed in Second Phase 3 Clinical Trial
– SynAIRgy Compares AD109 to Placebo Over 6 Months in People with OSA who Are Intolerant of or Refuse Positive Airway Pressure (PAP) Therapy, the Current Standard of Care – Part of a two-study registrational Phase 3 program that also includes LunAIRo which began enrollment in September 2023 Apnimed, Inc., […]
Potential Next Generation Dual Orexin Agonist for Narcolepsy in Development
NLS Pharmaceutics Ltd., a Swiss clinical-stage biopharmaceutical company focused on the discovery and development of innovative therapies for patients with rare and complex central nervous system (“CNS”) disorders, announced that NLS has entered into an exclusive worldwide option agreement with Aexon Labs, Inc., a privately held U.S. company (“Aexon Labs”), […]
Jazz Pharmaceuticals Presents Latest Advancements at World Sleep 2023
Jazz Pharmaceuticals plc announced that the Company and its partners will present 14 abstracts from across its sleep medicine portfolio, including two oral presentations, at the 17th annual World Sleep 2023 Congress, held October 20-25 in Rio de Janeiro, Brazil. The oral presentations include findings from the real-world TENOR study, […]
Promising Results for Pitolisant in Prader-Willi Syndrome
Harmony Biosciences Holdings, Inc. announced the presentation of new secondary endpoint data, including improvements in behavioral disturbances, from its Phase 2 signal-detection study evaluating pitolisant for the treatment of excessive daytime sleepiness (EDS) in Prader-Willi syndrome (PWS) at the 2023 Foundation for Prader-Willi Research (FPWR) Symposium and Family Conference. The […]
Jazz Showcases Impact of Sleep Medicine Portfolio at Psych Congress 2023
Jazz Pharmaceuticals plc announced that six abstracts presenting data from across its sleep medicine portfolio were featured at the 36th annual Psych Congress, held September 6-10, 2023. One of the accepted abstracts provided a comprehensive review of clinical data that assessed the impact of oxybate on sleep quality, sleep architecture and […]
Promising Results for Narcolepsy Type 1 Treatment, but Safety Concerns Arise
Takeda announced that data from the Phase 2 study of orexin receptor 2 (OX2R) agonist TAK-994 in patients with narcolepsy type 1 (NT1) was published in The New England Journal of Medicine. These data represent the first-ever clinical data to be published of an oral orexin agonist in NT1. The […]
Avadel Pharmaceuticals Receives FDA Approval of Bedtime Narcolepsy Treatment
Avadel Pharmaceuticals plc announced that the U.S. Food & Drug Administration (FDA) has granted final approval to LUMRYZ, an extended-release formulation of sodium oxybate indicated to be taken once at bedtime for the treatment of cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy. With final approval, LUMRYZ becomes […]
New AASM Guideline: Management of REM Sleep Behavior Disorder in Adults
A new clinical practice guideline developed by the American Academy of Sleep Medicine provides recommendations for the management of REM sleep behavior disorder in adults. The guideline, available online as an accepted paper in the Journal of Clinical Sleep Medicine, updates the AASM’s previous guidance published in 2010. Several clinical trials […]













