New nightly pill slashes sleep apnea events by roughly 44% in phase 3 trial

Researchers reported that AD109, a combination of aroxybutynin and atomoxetine, cut nightly breathing interruptions by roughly 44% in a six-month, phase 3 trial involving 646 U.S. and Canadian adults with obstructive sleep apnea who could not use CPAP. The study, published in the American Journal of Respiratory and Critical Care Medicine, also showed improvements in oxygen desaturation index and overall hypoxic burden, with more than 40% of patients shifting to a less severe classification and 18% attaining complete disease control.

The most common adverse events were dry mouth, nausea, insomnia and urinary difficulty, leading about 21% of participants to discontinue the drug. investigators highlighted the safety profile as acceptable. AD109 has received Fast Track designation from the FDA, and Apnimed has submitted a New Drug Application, aiming for a potential decision in the first quarter of 2027. First author Patrick John Strollo, MD, suggested the pill could broaden treatment options for the many patients who remain untreated due to CPAP intolerance.