Due to rising cases of stress, depression, obesity, extended work hours, and a high rate of diabetes, Japan's market for sleep apnea diagnostic equipment is anticipated to see significant growth, according to a recent forecast.
Based on consultation with the US Food and Drug Administration, Apnimed plans to begin two phase 3 registration trials in the second half of 2023.
The randomized, placebo-controlled segment of the study showed that AD109 had a statistically significant and clinically meaningful difference from placebo after a single dose in the patients’ hypoxic burden.
Topline results from a proof-of-concept randomized, controlled, double-blind, single-dose, crossover study of sleep apnea pill candidates.
Read MoreApnimed announced the dosing of the first patient in a study of the company’s lead investigational oral medication for the treatment of OSA.
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...
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The administration of reboxetine plus oxybutynin before bedtime greatly decreased OSA severity and increased next-day vigilance after 1 week.
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A total of 30 participants will be enrolled. Each participant will receive two different dose levels of AD109, and placebo, at bedtime.
Read MoreApnimed’s AD109 is dosed once-daily at bedtime, designed to treat OSA patients across a broad spectrum of disease severity.
Read MoreIn the phase 1 trial, R-oxybutynin demonstrated a favorable PK profile and was well tolerated with no adverse events.
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The disorder has several different causes, researchers are learning. That finding opens the door for personalized therapies—and perhaps even effective drugs.
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