Apnimed shares positive results for sleep apnea pill 

CAMBRIDGE, Mass. - Apnimed has announced positive topline results from its pivotal Phase 3 SynAIRgy clinical trial evaluating the efficacy and safety of AD109 in adults living with mid, moderate and severe OSA and across all weight classes. The SynAIRgy trial met its primary endpoint: mean change from baseline in the apnea-hypopnea index (AHI) at 26 weeks compared to placebo (p=0.001). “Today is a landmark moment for Apnimed and for millions living with OSA who have long struggled with limited treatment options,” said Larry Miller, MD, CEO of Apnimed. “The positive results from our Phase 3 SynAIRgy trial bring us closer to realizing our vision of offering a simple, safe and effective oral drug — one that is grounded in science, driven by unmet need, and centered on people with OSA. We believe these results represent the dawn of a new era in the OSA treatment paradigm.” Apnimed  plans to submit a New Drug Application for AD109 to the U.S. Food and Drug Administration by early 2026 for regulatory review. The company also anticipates the availability of topline data in Q3 2025 from the second Phase 3 LunAIRo trial, a one-year study of AD109 in adults with OSA. AD109 is designed to be the first pharmacological treatment to improve oxygenation during sleep by directly addressing the neuromuscular root cause of upper airway collapse in people with OSA. It is a combination of aroxybutynin, a novel antimuscarinic, and atomoxetine, a selective norepinephrine reuptake inhibitor (NRI). Apnimed says AD109, which is a once-daily pill taken at bedtime, is designed to lower the complexity of intervention and may help more people benefit from effective, restorative sleep.