Incannex Meets with FDA in Pre-IND Meeting for Sleep Apnea Drug Candidate
Incannex characterized the pre-investigational new drug application (pre-IND) meeting about IHL-42X as “highly constructive.”
Category: Emerging Compounds
Emerging Compounds
Latest
Emerging Compounds
LatestSulthiame Lowers AHI At Least 50% in Trial
Sulthiame, a carbonic anhydrase inhibitor, lowered obstructive sleep apnea by more than 20 events/hour, a notable decline for a drug trial.
Emerging Compounds
Latest
Two Existing Drugs Lower CPAP Severity by 30% in Trial
These medications increased the muscle activity around airways, with the drugs reducing the severity of sleep apnea by up to one-third.
Axsome Begins Phase 3 Trial for Narcolepsy Drug Candidate
The primary endpoint will be the frequency of cataplexy attacks. Other symptoms of narcolepsy as well as safety will also be assessed.
Read MoreREST-ON Trial Data, for Once-Nightly Sodium Oxybate, Published in Peer-Reviewed Journal
“We believe FT218 has tremendous potential to provide clinically meaningful results for people with narcolepsy.”
Read MoreHarmony Acquires Narcolepsy Drug Candidate with Novel Mechanism of Action
HBS-102 is a MCHR antagonist that has the potential to offer a novel approach to the treatment of narcolepsy including the symptoms of REM sleep dysregulation.
Read MoreFDA 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.
Read MoreIdorsia ‘Progressing Very Well’ with Prep for Anticipated Launch of Insomnia Drug Candidate
Allschwil, Switzerland-based Idorsia Ltd recently announced its financial results for the first half of 2021, at which time its drug daridorexant for the treatment of insomnia under review with United States FDA, EMA, and Swissmedic.
Read MoreSleep Specialist Becomes SVP, Medical Affairs at Sleep Apnea Pill Development Company Apnimed
Apnimed, a clinical-stage company focused on advancing pharmacologic treatments for obstructive sleep apnea and related disorders, has named David P. White, MD, senior vice president of medical affairs. In this role, White will...
Read MoreKnock-Out Mouse Model Study Data Confirms Mazindol’s Orexin Pathway Activation for Treating Narcolepsy
The study demonstrated that knock out mice were 70% less sensitive to mazindol compared to normal mice, confirming mazindol’s potent activity as an OX2R agonist.
Read MoreAvadel Presents Data from Phase 3 Trial Supporting Clinical Benefit of FT218 in Patients with Narcolepsy
“The new data analyses showing that FT218 improved excessive daytime sleepiness in patients with narcolepsy, both with and without cataplexy, regardless of stimulant use, are important for this patient population.”
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Sleep Apnea Pill Data Presented at ATS 2021: ‘These Data Reinforce the Potential of Pharmacotherapy in Treating OSA’
The administration of reboxetine plus oxybutynin before bedtime greatly decreased OSA severity and increased next-day vigilance after 1 week.
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Genes Reveal Secrets of Circadian Rhythm Sleep Disorders
In time, scientists’ growing understanding of the genetic underpinnings of delayed sleep phase and other circadian disorders could pave the way to novel therapeutics.
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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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