First Patient Dosed in Phase 3 Trial of OSA Drug Candidate AD109
The first patient has been dosed in Apnimed's phase 3 study of AD109, a drug candidate for obstructive sleep apnea.
The first patient has been dosed in Apnimed's phase 3 study of AD109, a drug candidate for obstructive sleep apnea.
Centessa Pharmaceuticals shared details on its upcoming oral presentation, which will focus on ORX750, a drug in preclinical development for the treatment of narcolepsy and other sleep disorders.
The FDA has granted its Fast Track designation for the investigation of tirzepatide for the treatment of adults with obesity or who are overweight with weight-related comorbidities (including obstructive sleep apnea) to facilitate weight loss.
Harmony Biosciences reported second-quarter business updates, showcasing an upswing in prescription demand for its narcolepsy drug, Wakix.
Read MoreIn a phase 2 trial involving patients with narcolepsy type 1, TAK-994 demonstrated statistically significant improvements in wakefulness and reduced cataplexy rates compared to placebo but was associated with hepatotoxic effects.
Read MoreThe IND application details the clinical trial protocol for the IND opening clinical trial, which is a multi-site phase 2/3 trial investigating IHL-42X, a cannabinoid combination product, for the treatment of OSA.
Read MoreThe study will further investigate pitolisant in children, adolescents, and adults with Prader-Willi syndrome experiencing excessive daytime sleepiness.
Read MoreThe phase 2/3 clinical trial will assess the safety and efficacy of IHL-42X, a cannabinoid combination product, in people with OSA who are intolerant, non-compliant, or naïve to CPAP.
Read MoreThe clinical trial will assess the pharmacokinetics and tolerability of the two active pharmaceutical ingredients in IHL-42X: dronabinol (THC) and acetazolamide.
Read MoreThe AMAZE program, commencing this summer at multiple sites in the US, will encompass two almost-identical double-blind phase 3 studies investigating mazindol ER versus placebo in adult patients with narcolepsy.
Read MoreIHL-42X, a cannabinoid combination product, is being developed as a pharmacological option for obstructive sleep apnea.
Read MoreSwiss clinical-stage biopharmaceutical company NLS Pharmaceutics Ltd announced positive data from five in vitro drug-drug interaction studies investigating mazindol.
Read MoreHarmony Biosciences presented safety and efficacy data from a phase 2 study evaluating pitolisant for the treatment of excessive daytime sleepiness in people with Prader-Willi syndrome at SLEEP 2023.
Read MoreThe presentations include data from the SHARP study in patients with excessive daytime sleepiness associated with OSA, real-world data from OSA patients taking Sunosi as part of the SURWEY study in Germany, healthcare resource use in OSA patients with residual EDS, and effect sizes and numbers needed to treat analyses.
Read MoreTokyo-based Eisai will present eight poster presentations, including the latest data on its in-house discovered orexin receptor antagonist lemborexant (Dayvigo) at SLEEP 2023.
Read MoreThe phase 3 registrational INTUNE study will evaluate the safety and efficacy of pitolisant in adult patients with idiopathic hypersomnia.
Read MoreThe financing will support clinical trial research and development for a new formulation of dronabinol for the treatment of obstructive sleep apnea.
Read MoreBased on consultation with the US Food and Drug Administration, Apnimed plans to begin two phase 3 registration trials in the second half of 2023.
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