A phase 3 clinical trial presented at the 2026 ATS International Conference demonstrated that the oral medication AD109 significantly improved obstructive sleep apnea (OSA) symptoms. The study, titled “Aroxybutynin and Atomoxetine (AD109) for Obstructive Sleep Apnea: A Randomized Phase 3 Trial,” published in the American Journal of Respiratory and Critical Care Medicine, involved 646 adults with mild to severe OSA who either refused or could not tolerate continuous positive airway pressure (CPAP) therapy. Participants receiving AD109 experienced a 44% reduction in the apnea-hypoxia index, compared to an 18% reduction in the placebo group. Additionally, over 40% of AD109 recipients improved enough to be reclassified into a less severe OSA category, and 18% achieved complete disease control.
AD109, which combines aroxybutynin and atomoxetine, targets neuromuscular dysfunction contributing to airway collapse during sleep. The trial, conducted across 69 sites in the U.S. and Canada over six months, also reported improvements in other nighttime oxygen metrics, such as the oxygen desaturation index and hypoxic burden. While the treatment was generally well-tolerated, approximately 21% of patients discontinued due to mild side effects, including dry mouth, nausea, insomnia, and difficulty urinating. Given the promising results, AD109 has received Fast Track designation from the FDA, and its manufacturer, Apnimed, has submitted a New Drug Application with an anticipated FDA decision in the first quarter of 2027. Source