Tag: CATAPLEXY

Takeda's ORZEYFUL Approved in China for Narcolepsy Type 1
Narcolepsy Pharmacological

New Study: Takeda’s Oveporexton Improved Daily Function, Cognition and Nighttime Sleep for Narcolepsy Type 1

New data presented by Takeda at SLEEP 2026 this week continues to build the case for oveporexton (TAK-861) as a potential disease-modifying treatment for narcolepsy type 1 (NT1). Oveporexton is designed to address the root cause of the disease, targeting the underlying orexin deficiency responsible for NT1. Results from two pivotal […]

Harmony Biosciences Receives U.S. FDA Approval for WAKIX (pitolisant) for the Treatment of Cataplexy in Pediatric Narcolepsy
Narcolepsy Pharmacological

Harmony Biosciences Receives FDA Approval for WAKIX for the Treatment of Cataplexy in Pediatric Narcolepsy

Harmony Biosciences announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental new drug application (sNDA) for WAKIX® (pitolisant) tablets for the treatment of cataplexy in pediatric patients 6 years of age and older with narcolepsy. WAKIX is now the first-and-only FDA-approved non-scheduled treatment for pediatric and adult […]

Takeda's ORZEYFUL Approved in China for Narcolepsy Type 1
Pharmacological Narcolepsy

Takeda Presents Orexin Data from Landmark Oveporexton (TAK-861) Phase 3 Program in Narcolepsy Type 1 at World Sleep 2025

Takeda will present data from two global Phase 3 double-blind, placebo-controlled studies of oveporexton (TAK-861)1, a potential first-in-class investigational oral orexin receptor 2 (OX2R)-selective agonist in narcolepsy type 1 (NT1), during multiple oral presentations at the World Sleep 2025 Congress in Singapore.   Both the FirstLight (TAK-861-3001) and RadiantLight (TAK-861-3002) […]

SleepWorld Magazine Pharmacological

Sleep Pharmaceutical Update Nov/Dec 2024

Sleep Pharmaceutical Update Nov/Dec 2024 Eight abstracts presenting data from across the sleep portfolio of Jazz Pharmaceuticals plc were featured at the 37th annual Psych Congress, held  Oct. 29–Nov. 2, 2024 in Boston. That data included topline results of the Phase 4 DUET (Develop hypersomnia Understanding by Evaluating low-sodium oxybate Treatment) trial, […]

Axsome Therapeutics axs-12
Pharmacological

Axsome Therapeutics Announces AXS-12 Achieves Primary Endpoint in Narcolepsy Phase 3 Trial

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 […]