Shots:
The US FDA has approved Genio system for pts with mod. to sev. obstructive sleep apnea (15 ≤ Apnea-Hypopnea Index ≤ 65); US commercialization is officially initiated
Approval was based on the DREAM trial, which met its 1 & 2EPs, showing a 63.5% AHI responder rate, 71.3% oxygen desaturation index responder rate, & 70.8% median AHI…
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.…
Shots:
Apnimed has reported topline P-III (SynAIRgy) trial data assessing AD109 (aroxybutynin 2.5mg/atomoxetine 75mg) vs PBO for 6mos. in 646 adults with mild to sev. OSA across all weight classes who are intolerant of or refuse CPAP therapy
Trial met its 1EP with a mean change in AHI at 26wks. & showed improvements across exploratory…

