Apnimed Advances FDA Filing after Second Pivotal Win for Oral Sleep Apnoea Drug

Apnimed's once-daily oral drug AD109 achieved positive topline results in the LunAIRo phase 3 trial, its second pivotal study for obstructive sleep apnea (OSA), reducing apnea-hypopnea index (AHI) by 46.8% compared to just 6.8% with placebo after 26 weeks.2 3 5

AD109 combines aroxybutynin 2.5 mg and atomoxetine 75 mg, aiming to improve upper airway muscle tone during sleep, targeting the root cause of OSA.3

The LunAIRo study enrolled 660 adult patients intolerant of or refusing CPAP therapy and found statistically significant, sustained improvements over a full year; safety data showed no serious treatment-related adverse events, with all being mild or moderate.2 3

A previous pivotal phase 3 trial, SynAIRgy, in 646 patients, also met its endpoint with a 55.6% reduction in AHI over six months.2 1

Based on combined data from LunAIRo and SynAIRgy, Apnimed intends to file a New Drug Application (NDA) with the FDA in early 2026, positioning AD109 as a first-in-class oral treatment option for OSA.1 2 4 5

Sources:

1. https://www.neurologylive.com/view/once-daily-oral-pill-obstructive-sleep-apnea-shows-promising-phase-3-results-paving-way-fda-submission

2. https://www.fiercebiotech.com/biotech/apnimeds-sleep-apnea-asset-goes-two-two-ph-3-solidifying-star-potential

3. https://www.psychiatrictimes.com/view/positive-topline-results-from-phase-3-trial-of-ad109-first-oral-pill-for-obstructive-sleep-apnea

4. https://firstwordpharma.com/story/5983155

5. https://www.prnewswire.com/news-releases/apnimed-reports-positive-topline-results-from-second-phase-3-trial-of-ad109-reinforcing-potential-of-first-oral-pill-for-obstructive-sleep-apnea-302511320.html

Sources:

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