Promising Results Reported for Oral Therapy for Obstructive Sleep Apnea

Treatment with AD109 (Apnimed, Cambridge, MA), an investigational oral therapy for obstructive sleep apnea (OSA), was found to significantly reduce the apnea-hypopnea index (AHI) at 26 weeks (P=.001), according to topline results from the phase 3 SynAIRgy clinical study (NCT05813275). AD109 treatment, which is a fixed-dose combination of aroxybutynin 2.5 mg and atomoxetine 75 mg, was associated with a mean AHI reduction of 55.6% from baseline and was generally well tolerated with no serious adverse events attributed to the medication. Apnimed announced that the company plans to submit a New Drug Application (NDA) for AD109 by early 2026.

SynAIRgy was a randomized, double-blind, placebo-controlled, 6-month trial enrolling 646 adults with mild to severe OSA across 73 US and Canadian centers. Participants were randomized 1:1 to receive either AD109 or placebo, taken once nightly at bedtime. All participants were either intolerant of or declined continuous positive airway pressure (CPAP) therapy.

In terms of key findings:

• AD109-treated participants showed a 55.6% reduction in AHI vs baseline (P=.001).
• There were meaningful improvements in oxygenation associated with AD109 treatment as defined by hypoxic burden (P<.0001) and oxygen desaturation index (P=.001).
• 51.2% of AD-109–treated participants showed a reduction in OSA severity category, and 22.3% achieved complete OSA control (AHI <5 events/hour)

“The results from SynAIRgy suggest that if approved, AD109 could offer a compelling new treatment option—a novel oral drug that targets the neuromuscular root cause of airway obstruction in sleep apnea and holds promise for transforming care for a broad range of patients,” said Patrick Strollo, Jr, MD, SynAIRgy clinical trial Study Chair and Vice Chair of Medicine for Veteran’s Affairs at the University of Pittsburgh School of Medicine.