The thought of histamines might conjure up images of itchy hives or the tickling sensation just before a sneeze, but scientists have come to realize there is much more to histamines than their connection to allergies. Recent research reveals that histamines play a vital role in wakefulness. Produced by brain […]
Tag: NARCOLEPSY
Accelerating Narcolepsy Research Together
Since its inception in 2008, Wake Up Narcolepsy (WUN) has donated over $1.39 million to narcolepsy research. We are a nonprofit organization committed to advancing narcolepsy awareness, education, and research. A large part of our mission involves raising and allocating funding to develop improved treatments and ultimately, find a cure. […]
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, […]
Avadel Pharmaceuticals Announces Favorable Ruling On Lumryz
Avadel Pharmaceuticals plc , a biopharmaceutical company focused on transforming medicines to transform lives, announced that yesterday, the U.S. District Court for the District of Columbia (“Court”) ruled in favor of the Food and Drug Administration (“FDA”) in a suit brought by Jazz Pharmaceuticals Inc. (“Jazz”) under the Administrative Procedure […]
FDA Approves LUMRYZ for Pediatric Narcolepsy Treatment
Avadel Pharmaceuticals plc announced today that the U.S. Food and Drug Administration (FDA) has approved its supplemental new drug application (sNDA) for LUMRYZ for the treatment of cataplexy or EDS in patients 7 years of age and older with narcolepsy. “This approval represents an important milestone for the narcolepsy community, […]
Centessa Receives FDA Clearance for Phase 1 Clinical Trial of Promising Narcolepsy Treatment
Centessa Pharmaceuticals plc announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug application (IND) to initiate a Phase 1 first-in-human clinical trial of ORX750 for the treatment of narcolepsy. ORX750 is an investigational, orally administered, highly potent and selective orexin receptor 2 (OX2R) agonist […]
Harmony Biosciences to Develop Potential Best-in-Class Oral Orexin-2 Receptor Agonist for Narcolepsy
Harmony Biosciences Holdings, Inc. has announced an exclusive licensing agreement with Bioprojet to develop, manufacture and commercialize TPM-1116, a highly potent and selective oral orexin-2 receptor (OX2R) agonist that will be evaluated for the treatment of narcolepsy and other sleep/wake disorders. TPM-1116 represents a new chemical series of OX2R agonists […]
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 […]
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 […]
Project Sleep Launches National Sleep Helpline
Official Release from Project Sleep Project Sleep is thrilled to announce the official launch of the Sleep Helpline™, a new, professionally-staffed national helpline providing timely and trusted resources to help individuals navigate sleep issues and sleep disorders at every step of the journey. “An estimated 50-70 million Americans live with a chronic […]












