Sleep Pharmaceuticals

Avadel Strengthens Portfolio with Exclusive License of Valiloxybate
Sleep Pharmaceuticals

Avadel Pharmaceuticals Strengthens Sleep Medicine Portfolio with Exclusive License of Valiloxybate from XWPharma Ltd

Avadel Pharmaceuticals plc, a biopharmaceutical company focused on transforming medicines to transform lives, and XWPharma Ltd. (“XWPharma”) together announced today that Avadel has entered into an exclusive global license agreement with XWPharma to develop and commercialize valiloxybate, a GABAB receptor agonist, for all indications, including the treatment of sleep disorders, such […]

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, […]

Alkermes Announces Initiation of Phase 3 Brilliance Studies Evaluating Alixorexton for the Treatment of Narcolepsy Type 1 and Type 2
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 […]