Pharmacological

Alkermes Announces Phase 3 Brilliance Studies Evaluating Alixorexton for Narcolepsy Type 1 and Type 2
Clinical Insights & Research Narcolepsy Pharmacological

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 […]

Sunrise Announces Landmark SUNSAS Trial Results, an At-Home Sleep Apnea Diagnostic Pathway Compared with PSG
Industry News Pharmacological

Sunrise Announces Landmark SUNSAS Trial Results, an At-Home Sleep Apnea Diagnostic Pathway Compared with PSG

Sunrise Group announced results from the SUNSAS clinical study, now published in The Lancet Regional Health – Europe, a leading international medical journal. Supported by the French Ministry of Health through the Forfait Innovation program, this study is the largest randomized controlled trial to date evaluating an at-home diagnostic pathway for obstructive […]

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 […]

Alkermes Avadel Aquisition
Acquisitions Pharmacological

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 […]

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

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
Pharmacological Company News

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. […]

Exploring how tirzepatide fits into the treatment model for obstructive sleep apnea
Pharmacological Sleep Apnea

A New Piece of the Puzzle

For the millions of people managing both obesity and obstructive sleep apnea (OSA), tirzepatide (Zepbound® and Mounjaro®, Eli Lilly and Co.) may offer a welcome approach to help reduce symptoms and improve overall health and quality of life. It’s been almost exactly a year since investigators of the SURMOUNT-OSA trial […]