Oral Sleep Apnea Pill AD109 Nears FDA Sign-Off After Phase 3 Win
A phase 3 trial of the oral drug AD109 (a combo of aroxybutynin and atomoxetine) reduced the apnea-hypopnea index by about 44% versus 18% with placebo over 26 weeks in 646 patients with mild–severe obstructive sleep apnea, with roughly 42% moving to a lower severity category and about 18% no longer meeting OSA criteria. Side effects were mild (dry mouth, nausea, insomnia). The FDA has fast-tracked AD109, with a decision anticipated in 2027, potentially offering a convenient alternative to CPAP for patients unable or unwilling to use the machine.
