Apnimed announces positive results for sleep apnea pill, plans FDA filing 

CAMBRIDGE, Mass. – Apnimed, a pharmaceutical company developing oral therapies for obstructive sleep apnea (OSA) and related conditions, announced positive topline results from its second pivotal Phase 3 trial of AD109 (aroxybutynin 2.5mg/atomoxetine 75mg). The 12-month LunAIRo study assessed the efficacy and safety of AD109 in adults with mild to severe OSA across various weight classes. The primary endpoint, measured at 26 weeks, was met with a 46.8% mean reduction in AHI compared to 6.8% with placebo (p<0.001). This reduction remained statistically significant at week 51 (p<0.001). AD109 was generally well-tolerated, with mostly mild to moderate side effects consistent with previous studies. No serious treatment-related adverse events were reported. LunAIRo’s results align with those from Apnimed’s earlier SynAIRgy Phase 3 trial, further supporting AD109’s safety and efficacy, the company says. “With two large Phase 3 studies now demonstrating a consistent and significant efficacy profile for AD109, we are closer to delivering the first oral pharmacotherapy for over 80 million U.S. adults with OSA,” said Larry Miller, MD, CEO of Apnimed. “We’re focused on ensuring we have the capabilities, people, and partnerships in place to bring this innovative drug to patients suffering from OSA and the clinicians who treat them.” AD109, a once-a-day pill taken at bedtime, is an anti-apneic neuromuscular modulator, combining aroxybutynin, a novel antimuscarinic, and atomoxetine, a selective norepinephrine reuptake inhibitor (NRI) to target the underlying neuromuscular root cause of OSA. Apnimed plans to submit a New Drug Application to the FDA in early 2026.