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Apnimed Pill Cuts Sleep Apnea Events in Phase 3 as Company Seeks FDA Approval

The once-nightly therapy targets airway muscle tone to give patients who cannot use CPAP a possible oral alternative.

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Overview

  • The SynAIRgy phase 3 trial, presented Monday at the ATS conference, found AD109 cut the hourly apnea–hypopnea index by about 44% versus 18% on placebo.
  • The six-month study ran at 69 sites in the United States and Canada and enrolled 646 adults who refused or could not tolerate CPAP.
  • Patients on AD109 also showed gains in oxygen measures, including fewer oxygen drops during the night and lower overall hypoxic burden.
  • Side effects were mostly dry mouth, nausea, insomnia, and trouble urinating, and about 21% stopped the drug because of adverse events.
  • Apnimed has filed an FDA application under Fast Track and, if accepted, expects a potential decision in the first quarter of 2027, which could open a new option for untreated patients.