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.”
Incannex characterized the pre-investigational new drug application (pre-IND) meeting about IHL-42X as “highly constructive.”
Sulthiame, a carbonic anhydrase inhibitor, lowered obstructive sleep apnea by more than 20 events/hour, a notable decline for a drug trial.
These medications increased the muscle activity around airways, with the drugs reducing the severity of sleep apnea by up to one-third.
The primary endpoint will be the frequency of cataplexy attacks. Other symptoms of narcolepsy as well as safety will also be assessed.
Read More“We believe FT218 has tremendous potential to provide clinically meaningful results for people with narcolepsy.”
Read MoreHBS-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 MoreThe 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 MoreAllschwil, 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 MoreApnimed, 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 MoreThe 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 More“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.”
Read MoreThe administration of reboxetine plus oxybutynin before bedtime greatly decreased OSA severity and increased next-day vigilance after 1 week.
Read MoreIn time, scientists’ growing understanding of the genetic underpinnings of delayed sleep phase and other circadian disorders could pave the way to novel therapeutics.
Read MoreThe AAN presentation further quantifies the previously reported Phase 3 top-line results.
Read More“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 MoreNeurology Advisor interviews Aleksandra M. Kwasnik, MD, who co-authored a recent review on cannabinoids that was published in Current Pulmonology Reports.
Read MoreFT218 exhibited a pharmacokinetic profile that supported once-nightly dosing with adequate concentrations maintained throughout the night.
Read MoreResponsibilities include leading the US commercial launch of the company’s lead program, once-nightly FT218, pending regulatory approval.
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