Apnimed announces positive results in clinical trial of sleep apnea medication

On Could 19, 2025, Apnimed introduced constructive topline outcomes from its Part 3 SynAIRgy medical trial of AD109 (aroxybutynin 2.5 mg/atomoxetine 75 mg), an investigational once-daily oral tablet for adults with delicate, reasonable and extreme obstructive sleep apnea throughout all weight lessons.

About AD109

AD109 is a once-daily tablet that goals to enhance oxygenation throughout sleep in individuals with sleep apnea by concentrating on the neuromuscular root reason behind higher airway collapse. It combines aroxybutynin, a novel antimuscarinic, and atomoxetine, a selective norepinephrine reuptake inhibitor, to extend signaling to the higher airway muscular tissues throughout sleep by concentrating on the neurobiology of the hypoglossal motor nucleus.

AD109 met the first endpoint within the SynAIRgy medical trial: imply change from baseline within the apnea-hypopnea index (AHI) at 26 weeks in comparison with placebo. Examine contributors handled with AD109 achieved a imply discount in AHI of 55.6% from baseline.

Along with assembly the first endpoint, AD109 additionally demonstrated enhancements in oxygenation as assessed by hypoxic burden and oxygen desaturation. Moreover, 51.2% of contributors handled with AD109 confirmed a discount in sleep apnea illness severity class, whereas 22.3% of contributors achieved accomplished illness management, outlined as an AHI of lower than 5 occasions per hour.

Apnimed reported that AD109 was typically well-tolerated, and the most typical opposed occasions have been in line with earlier AD109 medical trials. No severe opposed occasions associated to AD109 have been reported within the SynAIRgy trial.

The SynAIRgy trial was a randomized, double blind, placebo-controlled, parallel-arm six-month medical trial of AD109 in contributors with obstructive sleep apnea who’re illiberal to or refuse CPAP remedy. It concerned 646 grownup sufferers, together with 49.1% females, people from a number of racial teams, and a variety of weight lessons, with sleep apnea severity ranges distributed as delicate (34.4%), reasonable (42.4%), and extreme (23.2%).

In accordance with the corporate’s press launch, Apnimed expects topline outcomes from its second Part 3 medical trial, LunAIRo, in Q3 2025. It plans to submit a New Drug Utility for AD109 to the U.S. FDA by early 2026 for regulatory evaluate.

About Obstructive Sleep Apnea

Obstructive sleep apnea is a prevalent and severe sleep problem involving repeated blockage of the airway throughout sleep, resulting in paused respiratory and oxygen deprivation. Generally brought on by the collapse of throat tissues, it can lead to loud loud night breathing, choking noises and frequent awakenings, probably contributing to well being issues corresponding to hypertension, coronary heart illness, stroke, diabetes and melancholy.

Sleep apnea may be handled with choices corresponding to CPAP remedy, oral home equipment, surgical procedure, weight administration, positional remedy and life-style modifications. As well as, the FDA has authorised one prescription remedy, Zepbound (tirzepatide), for adults with reasonable to extreme obstructive sleep apnea and weight problems.

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