FDA Sets Target Action Date for Oral Obstructive Sleep Apnea Therapy
KEY TAKEAWAYS
- The FDA accepted Apnimed’s NDA for AD109, an investigational once-nightly oral therapy for adults with obstructive sleep apnea.
- The agency assigned a PDUFA target action date of February 28, 2027.
- The submission is supported by phase 3 SynAIRgy and LunAIRo data showing reductions in apnea-hypopnea index and improved oxygenation measures.
The FDA accepted the new drug application (NDA) for AD109 (aroxybutynin 2.3 mg/atomoxetine 75 mg; Apnimed, Cambridge, MA), an investigational oral therapy for adults with obstructive sleep apnea (OSA). The agency assigned a Prescription Drug User Fee Act target action date of February 28, 2027.
AD109 is a once-daily oral tablet taken at bedtime, which is being developed to address neuromuscular dysfunction contributing to upper airway collapse during sleep. The fixed-dose combination includes aroxybutynin, an antimuscarinic agent, and atomoxetine, a selective norepinephrine reuptake inhibitor. According to a statement from Apnimed, if approved, AD109 could become the first oral pharmacologic therapy for OSA.
The NDA is supported by Apnimed’s phase 3 clinical program, including the randomized, double-blind, placebo-controlled SynAIRgy (NCT05813275) and LunAIRo trials (NCT05811247) in adults with mild, moderate, and severe OSA.
Phase 3 Findings
- AD109 was associated with statistically significant reductions in apnea-hypopnea index across the phase 3 program.
- Oxygenation measures also improved, including hypoxic burden and oxygen desaturation index.
- AD109 was generally well tolerated; the most common adverse events were dry mouth, insomnia, and nausea.
OSA is a chronic sleep-related breathing disorder associated with recurrent upper airway collapse, intermittent oxygen deprivation, and increased cardiovascular, neurocognitive, and cardiometabolic risk.