Alliance of Sleep Apnea Partners Applauds FDA Submission of AD109, Hailing a Potential New Era for Sleep Apnea Patients

CONTACT:
Monica P. Mallampalli, PhD
President & CEO
Alliance of Sleep Apnea Partners
1-855-545-1717
info@apneapartners.org
www.apneapartners.org
 

ELLICOTT CITY, Md. — The Alliance of Sleep Apnea Partners (ASAP) today celebrated a landmark development for the more than 54 million Americans living with obstructive sleep apnea (OSA): Apnimed, Inc. has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for AD109, an investigational once-nightly oral pill that could become the first approved pharmacologic treatment for OSA.

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For decades, positive airway pressure (PAP) medical device therapy has been the gold- standard treatment for OSA. In recent years, newer options have emerged, including implantable upper airway stimulation devices and GLP-1 receptor agonists. But AD109 stands apart as something entirely different as a once-nightly oral pill designed as a standalone treatment that directly addresses the neuromuscular root cause of OSA for a broad range of patients.

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“This FDA submission is a moment of real hope and AD109 represents exactly what patients have needed, access to more treatments that work for them. For physicians, it is a new tool in the toolbox that can be used alone or perhaps alongside other therapies." Dr. Monica Mallampalli, President and CEO, Alliance of Sleep Apnea Partners. “We have always believed in the right treatment for the right patient, and this FDA submission brings that vision within reach."

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Phase 3 Clinical Evidence

The NDA submission is supported by results from two landmark Phase 3 clinical trials — SynAIRgy and LunAIRo conducted by Apnimed. In these trials, AD109 achieved significant reductions in the apnea-hypopnea index (AHI), the standard measure of OSA severity, at 26 weeks, meeting primary endpoints in both studies. The therapy also demonstrated meaningful improvements in oxygenation outcomes, including oxygen desaturation index and hypoxic burden. 

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AD109 is a combination of two specific medications, aroxybutynin and atomoxetine, that act together on the throat muscles to prevent the airway from collapsing during sleep. The Phase 3 SynAIRgy trial results were published recently in the American Journal of Respiratory and Critical Care Medicine (AJRCCM) and shared during the 2026 American Thoracic Society Conference. A second publication, a review article published in the American Journal of Respiratory Cell and Molecular Biology examines the role of neuromuscular dysfunction in OSA and the development of AD109. 

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AD109 has received Fast Track designation from the FDA, which recognizes its potential to address a significant unmet need. Based on FDA feedback, Apnimed anticipates a potential PDUFA target action date in the first quarter of 2027, pending FDA acceptance of the NDA for review.

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What This Means for Patients

Untreated sleep apnea is associated with serious health consequences, including increased risk of cardiovascular disease, diabetes, stroke, and depression. Yet adherence to CPAP therapy remains a persistent challenge. An effective oral option could dramatically expand treatment access, particularly for the estimated tens of millions of Americans who are CPAP-intolerant or have declined treatment altogether.

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ASAP has long advocated for expanded treatment options that reflect the real-world needs of patients. We urge the FDA to prioritize its review of this application and look forward to working with all stakeholders to support patient access should AD109 receive approval.

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About Alliance of Sleep Apnea Partners

The Alliance for Sleep Apnea Partners (ASAP) is a U.S. based patient-oriented non-profit organization dedicated to improving the lives of people with sleep apnea through education, advocacy and support. Founded in 2018, ASAP is committed to promoting screening, diagnosis, treatment, and management of sleep apnea on behalf of the patient community to advance the lifelong well-being of sleep apnea patients. Visit us at apneapartners.org for more information.