Sleep Pharmaceuticals

Clinical Trial of Early Morning Shift Workers Shows Promise of New Drug for Reducing Excessive Sleepiness
Clinical Insights Sleep Pharmaceuticals

Clinical Trial of Early Morning Shift Workers Shows Promise of New Drug for Reducing Excessive Sleepiness

Many more people work very early morning shifts than overnight ones, and a large proportion struggle with excessive sleepiness from shift work disorder, leading to problems with focus, performance and safety. A new clinical trial by investigators from Mass General Brigham found that the wake-promoting drug solriamfetol (Sunosi) helped early […]

Alkermes Announces Phase 3 Brilliance Studies Evaluating Alixorexton for Narcolepsy Type 1 and Type 2
Narcolepsy Research/Studies Sleep Pharmaceuticals

Alkermes Announces Phase 3 Brilliance Studies Evaluating Alixorexton for Narcolepsy Type 1 and Type 2

Alkermes plc, announced the initiation of the Brilliance Studies, a phase 3 program evaluating the safety and efficacy of alixorexton compared to placebo in adults with narcolepsy type 1 (NT1) and narcolepsy type 2 (NT2). Alixorexton is the company’s novel, investigational, oral, selective orexin 2 receptor (OX2R) agonist in development […]

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

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 […]

Alkermes Avadel Aquisition
Industry News Sleep Pharmaceuticals

Alkermes Completes Acquisition of Avadel, Accelerating Entry Into Sleep Medicine Market

Alkermes plc and Avadel Pharmaceuticals plc, announced Alkermes’ completion of its acquisition of Avadel, a commercial-stage biopharmaceutical company. The acquisition adds Avadel’s FDA-approved product, LUMRYZ®, to Alkermes’ commercial portfolio, and provides Alkermes with a commercial organization experienced in this disease state. This strategic move accelerates Alkermes’ entry into the sleep […]

U.S. Food and Drug Administration Accepts New Drug Application and Grants Priority Review for Takeda’s Oveporexton (TAK-861) as a Potential First-in-Class Therapy for Narcolepsy Type 1
Narcolepsy Sleep Pharmaceuticals

U.S. FDA Accepts New Drug Application and Grants Priority Review for Takeda’s Oveporexton (TAK-861) as a Potential First-in-Class Therapy for Narcolepsy Type 1

Takeda announced that the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) and granted Priority Review for oveporexton (TAK-861) for the treatment of narcolepsy type 1 (NT1). Oveporexton is an investigational oral orexin receptor 2 (OX2R)-selective agonist designed to address the underlying orexin deficiency that causes […]

quviviq Daridorexant dual orexin receptor antagonist
Sleep Pharmaceuticals Product/Vendor Updates

QUVIVIQ Wins Best Biotechnology & Pharmaceutical Product

Idorsia Ltd announces that its novel treatment for insomnia disorder QUVIVIQ (Daridorexant) has been awarded the inaugural Prix Galien Bridges Award in the category of “Best Biotechnology & Pharmaceutical Product”. The award recognizes groundbreaking medicines, including biologics, gene therapies, and traditional pharmaceutical compounds, that advance patient care through scientific innovation. […]