Clinical Insights

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 […]

New Study Shows Sunrise’s AI-Powered Measure of Respiratory Effort, REMOV, Better Reflects OSA Symptoms Than Traditional PSG Metrics
Obstructive Sleep Apnea Research/Studies Testing Modalities/Diagnostics

Sunrise’s AI-Powered Measure of Respiratory Effort, REMOV, Better Reflects OSA Symptoms Than Traditional PSG Metrics

Sunrise Group, a pioneer in medical device innovation and sleep care, today announced a new peer-reviewed study in Nature Communications Medicine. Sunrise developed the only home sleep test with respiratory effort measurement that has been validated against esophageal pressure, the reference standard. The study reveals that REMOV, the Sunrise-specific marker […]

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 […]

aesyra Intelligent Oral Appliance Uses Biofeedback to Reduce Bruxism by 60%
Dental Sleep Medicine Product/Vendor Updates

AesyBite Oral Appliance Uses Biofeedback to Reduce Bruxism by 60%

Aesyra SA has announced the successful completion of its clinical investigation evaluating the efficacy and safety of AesyBite™ Active, an intelligent oral appliance designed to treat and prevent sleep bruxism through biofeedback. The clinical investigation demonstrated that AesyBite™ Active achieved a statistically significant and clinically meaningful reduction in sleep bruxism activity, exceeding the […]

Patch-Based Onera Sleep Test Demonstrates PSG Accuracy Outside the Sleep Lab
Clinical Insights Home Sleep Testing (HST) Industry News Polysomnography Respiratory

Patch-Based Onera Sleep Test Demonstrates PSG Accuracy Outside the Sleep Lab

Onera Health has announced the publication of a multicenter validation study of its Onera Sleep Test System (STS) in the Journal of Clinical Sleep Medicine, the official journal of the American Academy of Sleep Medicine. The study demonstrated that the patch-based Onera STS home-polysomnography (hPSG) performs comparably to gold-standard in-lab […]