Apnimed touts Phase III success for first-ever sleep apnea pill

Cambridge, USA-based Apnimed today announced positive top-line results from its pivotal Phase III SynAIRgy clinical trial evaluating the efficacy and safety of its lead candidate AD109 (aroxybutynin 2.5mg/atomoxetine 75mg) in adults living with mild, moderate and severe obstructive sleep apnea (OSA), and across all weight classes.

The SynAIRgy trial met its primary endpoint: mean change from baseline in the apnea-hypopnea index (AHI) at 26 weeks compared to placebo (p=0.001). The top-line results for the primary and multiple secondary endpoints were similar to the results observed in the previous four-week MARIPOSA Phase IIb clinical trial.

AD109 was generally well-tolerated, and the most common adverse events were consistent with earlier AD109 clinical trials. No serious adverse events related to AD109 were reported in the SynAIRgy trial.