At the 2026 ATS International Conference in Orlando, Florida, researchers presented findings from a large phase 3 clinical trial showing that AD109, a once-nightly oral medication, effectively managed obstructive sleep apnea (OSA). This treatment is notable for targeting the underlying neuromuscular causes of airway collapse, making it the first of its kind for OSA.
Read More
The trial, named SynAIRgy, involved 646 adults with mild to severe OSA who either could not tolerate or chose to forgo traditional Continuous Positive Airway Pressure (CPAP) therapy. Results indicated that patients taking AD109 experienced a 44 percent decrease in their apnea-hypoxia index, compared to an 18 percent reduction in the placebo group. Additionally, improvements in overall blood oxygen levels and oxygen desaturation were recorded.
First author Dr. Patrick John Strollo, a sleep medicine physician at the University of Pittsburgh Medical Center, expressed optimism about the results, stating, "These findings provide encouraging evidence that targeting neuromuscular dysfunction can lead to significant clinical outcomes, which aligns with our current understanding of the disease's biology."
AD109 is a combination of the medications aroxybutynin and atomoxetine, which work to support throat muscles and prevent airway collapse during sleep. Over 40 percent of participants noted an improvement in disease severity, while 18 percent achieved full control over their OSA symptoms.
Although Continuous Positive Airway Pressure therapy is widely recognized as the standard for treating OSA, many patients struggle with its use. Dr. Strollo highlighted the need for alternative therapies, insisting that an oral medication addressing the neuromuscular factors of airway collapse could significantly expand treatment options for those currently untreated.
The trial demonstrated a generally favorable safety profile for AD109, with mild side effects such as dry mouth, nausea, and insomnia. However, around 21 percent of participants discontinued the medication due to these side effects.
AD109 has received Fast Track designation from the FDA, acknowledging the critical demand for effective and tolerable medications for OSA. Apnimed has submitted a New Drug Application (NDA) for AD109 to the FDA, anticipating a potential action date in the first quarter of 2027, contingent upon the FDA's acceptance of the application.
The detailed results of this trial will be published in the American Journal of Respiratory and Critical Care Medicine, along with a complementary mechanistic review in the American Journal of Respiratory Cell and Molecular Biology.