Apnimed said the FDA has accepted its New Drug Application for AD109, an investigational oral pill for adults with obstructive sleep apnea (OSA). The agency has set a Prescription Drug User Fee Act target action date of February 28, 2027.
AD109 combines aroxybutynin 2.3 mg and atomoxetine 75 mg and is being developed as a neurobiology‑focused pharmacologic treatment for OSA, a condition typically managed with devices such as continuous positive airway pressure. The company’s submission is supported by data from its Phase 3 program, including the SynAIRgy and LunAIRo randomized, double‑blind, placebo‑controlled trials in adults with mild, moderate, and severe disease.
In these studies, AD109 produced statistically significant reductions in apnea‑hypopnea index, a key measure of OSA severity, and showed improvements in oxygenation metrics such as hypoxic burden and oxygen desaturation index. The therapy was generally well tolerated, with the most common adverse events reported as dry mouth, insomnia, and nausea, consistent with earlier clinical findings.
Apnimed described the filing acceptance as an important milestone in efforts to broaden treatment options for patients who need more accessible alternatives to existing therapies. The company plans to work with the FDA during the review process as it seeks potential approval for AD109 as a pharmacologic option for adult OSA.
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