What the Phase 3 AD109 Data Mean for Sleep Apnea, With Patrick John Strollo, MD

Patrick John Strollo, MD, study author and sleep medicine physician at the University of Pittsburgh Medical Center, spoke with HCPLive at the American Thoracic Society (ATS) conference about key insights into the SynAIRgy trial findings, including patient-reported outcomes, tolerability, and where AD109 might fit in the OSA treatment landscape if approved.1,2

On the question of fatigue outcomes, Strollo noted that the primary analysis included the full trial population, as many of whom had mild OSA and relatively few fatigue complaints at baseline. When the analysis was narrowed to more symptomatic patients, specifically those with an Epworth Sleepiness Scale score above 10, the improvement in PROMIS fatigue scores was more pronounced. He also noted that fatigue can be difficult to measure in a society with widespread chronic sleep deprivation; AD109 may reduce sleep-disordered breathing, but it cannot reverse years of accumulated sleep debt.

Regarding the approximately 21–25% discontinuation rate due to adverse events, Strollo explained that the 3 main culprits, such as insomnia, dry mouth, and GI side effects, are consistent with the known profiles of both aroxybutynin and atomoxetine. He noted that the trial did not screen carefully for comorbid insomnia at enrollment, and patients with underlying insomnia may have been particularly susceptible to those effects. Patients who remained on treatment, however, tended to stay on drug and derive meaningful benefit.

Strollo highlighted the trial's notably broad population as a strength, 74% of participants had mild-to-moderate OSA, roughly a third were non-obese, and no specific signal emerged favoring the drug in any particular age, weight, demographic, or severity subgroup. He characterized AD109 as a first-in-class agent that, if approved, would represent another tool in the toolbox, particularly for the large population of patients who cannot tolerate or refuse PAP therapy and currently have limited options.

Disclosures: Strollo served as a consultant for Apnimed, Inspire Medical Systems, Cryosa, Somnomed, Philips Respironics, WisperSom, Biologix, Emmi Solutions, Zoll Medical Corporation, Restora, XII Medical and has received grant support through his institution from ResMed, Inspire Medical Systems, and Zoll Medical. He is also a non-Executive Director of Belluscura.

References

1. Patel S, Farkas R, Pho H, et al. (Poster Board # P194) Aroxybutynin and Atomoxetine (AD109) in Obstructive Sleep Apnea: A Pooled Analysis of the SynAIRgy and LunAIRo Phase 3 Trials. Poster presented at ATS 2026 on May 17.

2. Strollo P. AD109 Effective as Oral Agent for Obstructive Sleep Apnea, With Patrick John Strollo, MD. HCPLive. May 19, 2026. Accessed May 20, 2026. https://www.hcplive.com/view/ad109-effective-oral-agent-obstructive-sleep-apnea-patrick-john-strollo-md.