Apnimed’s AD109 NDA Accepted by FDA for Obstructive Sleep Apnea

The U.S. Food and Drug Administration has accepted the New Drug Application for AD109 (aroxybutynin 2.3 mg/atomoxetine 75 mg), an investigational once-nightly oral therapy for adults with obstructive sleep apnea (OSA). The agency assigned a Prescription Drug User Fee Act target action date of February 28, 2027.

If approved, AD109 would become the first oral pharmacologic therapy for OSA, offering a potential alternative to device-based treatments that remain the current standard of care. The investigational therapy targets the neuromuscular dysfunction that contributes to upper airway collapse during sleep, addressing a key mechanism underlying the disease.

A Novel Approach to Treating OSA

Obstructive sleep apnea is a chronic sleep-related breathing disorder characterized by repeated collapse of the upper airway during sleep, causing intermittent oxygen deprivation and fragmented sleep. The condition affects an estimated 80 million people in the United States and approximately one billion people worldwide.

Untreated OSA is associated with increased risks of cardiovascular disease, metabolic disorders, cognitive impairment, and premature mortality. Although continuous positive airway pressure (CPAP) remains the standard treatment, many patients remain untreated or struggle with long-term adherence, highlighting the need for additional therapeutic options.

AD109 combines aroxybutynin, a novel antimuscarinic agent, with atomoxetine, a selective norepinephrine reuptake inhibitor. The once-nightly oral tablet is intended to improve upper airway muscle activity during sleep, helping maintain airway patency, improve oxygenation, and reduce obstructive breathing events.

Phase 3 Program Supported NDA Submission

The NDA is supported by results from Apnimed’s Phase 3 clinical development program, including the SynAIRgy (NCT05813275) and LunAIRo (NCT05811247) randomized, double-blind, placebo-controlled trials. The studies enrolled adults with mild, moderate, and severe obstructive sleep apnea.

Across both trials, AD109 demonstrated statistically significant reductions in the apnea-hypopnea index (AHI) compared with placebo. Treatment also improved clinically meaningful measures of oxygenation, including hypoxic burden and the oxygen desaturation index (ODI).

The therapy was generally well tolerated throughout the Phase 3 program. The most frequently reported adverse events were dry mouth, insomnia, and nausea, consistent with the safety profile observed in earlier clinical studies.

Leadership Highlights Regulatory Milestone

Kevin Lind, Chief Executive Officer of Apnimed, said the FDA’s acceptance of the NDA marks an important milestone as the company advances a potential new treatment option for adults living with obstructive sleep apnea. He noted that the submission is supported by a comprehensive Phase 3 clinical data package developed over several years and reflects the company’s focus on addressing a significant unmet medical need through a convenient oral therapy.

Regulatory Path Forward

FDA acceptance of the NDA initiates the agency’s standard regulatory review process, with a decision expected by February 28, 2027.

If approved, AD109 would become the first oral pharmacologic therapy for obstructive sleep apnea and could expand treatment options for patients who are unable or unwilling to use device-based interventions. Approval, however, remains contingent on the FDA’s evaluation of the therapy’s efficacy, safety, manufacturing quality, and overall benefit-risk profile during its review.

Reference

Apnimed Announces FDA Acceptance of New Drug Application for AD109, An Investigational Oral Pill to Treat Adults with Obstructive Sleep Apnea  – Apnimed