Shots:
- The P-III (LunAIRo) trial assessed AD109 (aroxybutynin 2.5mg/atomoxetine 75mg; n=329) vs PBO (n=331) for 12mos. in 660 adults with mild to sev. OSA across all weight classes, who are intolerant of or refuse CPAP therapy
- Trial met its 1EP with a 46.8% vs 6.8% decrease in AHI at 26wks., which remained significant through Wk. 51. Exploratory & 2EPs showed better oxygenation & ≥50% AHI reduction in most pts at Wk. 26 & 51, plus depicted improved OSA severity in 45% at Wk. 26 & 47.5% at Wk. 51, & complete disease control in 22.9% & 22.5% at Wk. 26 & 51; further analysis is underway
- Also, Apnimed plans the US FDA’s NDA submission for AD109 by early 2026 supported by P-III (LunAIRo & SynAIRgy) trial results
Ref: PRNewsWire | Image: Apnimed| Press Release
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