Sleep Pharmaceuticals

EnsoData and Takeda to Improve Narcolepsy
Narcolepsy Sleep Pharmaceuticals

EnsoData, Takeda to Improve Narcolepsy Type 1 Diagnosis Using AI Tools and Technology

EnsoData has announced a collaboration with Takeda to jointly develop and validate AI-based polysomnography (PSG) algorithms to support more accurate and scalable diagnosis of narcolepsy type 1 (NT1). Upon successful validation and regulatory clearance, EnsoData will pursue the clinical availability and release of AI algorithms to enable future access, use, […]

Sleep Pharmaceuticals Narcolepsy Research/Studies

Phase 2 Study of Once-Daily Alixorexton in Patients With Narcolepsy Type 1

Alkermes plc today announced positive topline results from the randomized double-blind treatment period of the Vibrance-1 phase 2 study evaluating alixorexton in patients with narcolepsy type 1 (NT1). Alixorexton, formerly referred to as ALKS 2680, is the company’s novel, investigational, oral orexin 2 receptor (OX2R) agonist in phase 2 development as […]

Awareness Narcolepsy Product/Vendor Updates Sleep Pharmaceuticals

Harmony Strengthens Patent With ANDA Settlement

Harmony Biosciences Holdings, Inc., today announced a settlement agreement with Lupin Limited, resolving the patent infringement litigation related to Lupin’s Abbreviated New Drug Application (ANDA) for a generic version of WAKIX® (pitolisant hydrochloride). As part of the agreement, litigation in the United States District Court for the District of Delaware will […]

Idiopathic Hypersomnia Product/Vendor Updates Sleep Pharmaceuticals

Avadel’s LUMRYZ Receives FDA Orphan Drug Designation for Idiopathic Hypersomnia

Avadel Pharmaceuticals plc, a biopharmaceutical company focused on transforming medicines to transform lives, announced today that LUMRYZTM has been granted Orphan Drug Designation (ODD) from the U.S. Food & Drug Administration (FDA) for the treatment of Idiopathic Hypersomnia (IH). Specifically, ODD was granted based on the plausible hypothesis that LUMRYZ may […]

Axsome Therapeutics sunosi
Sleep Pharmaceuticals Industry News

Axsome Therapeutics Settles SUNOSI Patent Litigation with Hetero Labs Ltd.

Axsome Therapeutics, Inc. a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced that it has entered into a settlement agreement with Hetero Labs Ltd. and certain of its affiliates (Hetero) resolving patent litigation related to Axsome’s product SUNOSI® (solriamfetol). The litigation, which […]

apnimed SynAIRgy Phase 3 Results
Obstructive Sleep Apnea Research/Studies Sleep Pharmaceuticals

Apnimed Announces SynAIRgy Phase 3 Results

Apnimed, Inc., a pharmaceutical company building the industry-leading portfolio of first-in-class oral drug candidates that address the root causes of obstructive sleep apnea (OSA) and other sleep-related breathing diseases, today announced positive topline results from its pivotal Phase 3 SynAIRgy clinical trial evaluating the efficacy and safety of Apnimed’s lead […]