At a Glance Commentary.
Atomoxetine
Aroxybutynin
Scientific Knowledge on the Subject: AD109 (aroxybutynin 2.5 mg/atomoxetine 75 mg), an investigational, first-in-class, once-daily oral tablet, is designed to target the neuromuscular dysfunction underlying obstructive sleep apnea (OSA) by increasing upper airway muscle tone during sleep. In the phase 2b MARIPOSA trial, AD109 demonstrated significant improvement in the apnea–hypopnea index (AHI) in adults with mild-to-severe OSA over 4 weeks. An earlier phase 2 study suggested that AD109 may reduce AHI from the first dose. AD109 efficacy/safety beyond 4 weeks remain unknown.
What This Study Adds to the Field: SynAIRgy, a part of one of the largest clinical development efforts conducted for an OSA pharmacotherapy, is one of 2 phase 3 registrational trials evaluating the efficacy/safety of AD109. SynAIRgy is a randomized, double-blind, placebo-controlled, parallel-arm trial conducted in 646 participants with mild-to-severe OSA who were intolerant to or refused positive airway pressure therapy. SynAIRgy demonstrated significant improvements in airway obstruction and oxygenation across mild-to-severe OSA participants, supporting the potential for AD109 to be a new oral treatment option for patients with mild-to-severe OSA. Given existing OSA therapy limitations, AD109 may fill a large unmet medical need in providing patients with a pharmacologic therapy targeting the neuromuscular dysfunction underlying OSA pathogenesis.
https://academic.oup.com/ajrccm/advance-article/doi/10.1093/ajrccm/aamag215/8680221?login=false
https://en.wikipedia.org/wiki/Atomoxetine
https://drugs.ncats.io/substance/5BRQ29UUB7
