Avadel Awaits FDA Decision on Once-Nightly Sodium Oxybate for Narcolepsy; Launch Prep Progressing
Avadel Pharmaceuticals plc recently provided a corporate update and announced its financial results for the third quarter ended September 30, 2021.
Category: Emerging Compounds
Emerging Compounds
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LatestFDA Grants Breakthrough Therapy Designation to Takeda’s Investigational Oral Orexin Agonist for Narcolepsy Type 1
The designation was based, in part, on early phase and preliminary clinical data that indicates Takeda’s investigational oral orexin agonist may demonstrate substantially improved objective and subjective measurements of daytime wakefulness in NT1 patients.
Emerging Compounds
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In-Development Narcolepsy Drug Gets Canadian Patent Covering Novel Formulation of Controlled-Release Mazindol
The patent provides intellectual property protection for oral formulations containing immediate-release and sustained-release layers of mazindol for NLS Pharmaceutics's Quilience.
Jazz Pharmaceuticals Presents Phase 3 Results of Xywav in Idiopathic Hypersomnia
The AAN presentation further quantifies the previously reported Phase 3 top-line results.
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Avadel Presents New Data from Phase 3 Trial of Once-Nightly Sodium Oxybate
“The positive results previously disclosed from the REST-ON trial, regarding the three co-primary endpoints, are further bolstered by the secondary endpoints presented at AAN.”
Read MoreCan Cannabinoids Help Patients With Sleep Disorders?
Neurology Advisor interviews Aleksandra M. Kwasnik, MD, who co-authored a recent review on cannabinoids that was published in Current Pulmonology Reports.
Read MoreOnce-Nightly Sodium Oxybate Pharmacokinetic Studies Now Available Online
FT218 exhibited a pharmacokinetic profile that supported once-nightly dosing with adequate concentrations maintained throughout the night.
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Avadel Appoints Chief Commercial Officer to Lead Anticipated Launch of Once-Nightly Sodium Oxybate
Responsibilities include leading the US commercial launch of the company’s lead program, once-nightly FT218, pending regulatory approval.
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First Patient Dosed in Sleep Apnea Pill Second Phase 2 Clinical Trial
A total of 30 participants will be enrolled. Each participant will receive two different dose levels of AD109, and placebo, at bedtime.
Read MoreHarmony Biosciences Is Evaluating Pitolisant For Excessive Daytime Sleepiness in Patients with Prader-Willi Syndrome
The randomized, double-blind, placebo-controlled study is designed to assess the safety and efficacy of pitolisant in patients with PWS ages 6 to 65.
Read MoreKemPharm Adds Potential Therapy for Idiopathic Hypersomnia to Its Product Pipeline
KemPharm is investigating “KP1077” as a potential treatment for idiopathic hypersomnia (IH), a sleep disorder of excessive sleepiness.
Read MoreFirst Patient Dosed in Sleep Apnea Pill Phase 2 Clinical Trial
Apnimed’s AD109 is dosed once-daily at bedtime, designed to treat OSA patients across a broad spectrum of disease severity.
Read MoreNarcolepsy Market Assessment: Once-Nightly Sodium Oxybate May Appeal to More Patients Than Just Those on Twice-Nightly Dosing
“Six out of 10 sodium oxybate-eligible patients are not going on therapy today, with twice-nightly dosing being the primary reason cited.”
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A Hydrogen Sulfide Discovery in Rats Could Lead to New Treatments for Central Sleep Apnea
Inhibiting the production of hydrogen sulfide in rats resulted normal breathing patterns becoming gasping patterns.
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FDA Fast Tracks Xywav for Idiopathic Hypersomnia
“There is significant need for greater awareness of idiopathic hypersomnia, which can severely impact a person’s daily life, and can often be misdiagnosed or undiagnosed over a substantial period of time.”
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Reducing RLS Augmentation: Scientist Identifies a New Pathway to Maintain Restless Legs Syndrome Treatment Efficacy
A patent proposes a new treatment method that targets the increased D1 receptor levels in RLS patients experiencing augmentation.
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A Fecal Transplant Gave Healthy Mice Sleep Disturbances. Could Gut Microbiome Manipulation Treat Sleep Apnea?
Emerging evidence suggests the gut microbiome can influence health and sleep quality through the brain-gut microbiome axis.
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