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Sleep Apnea Pill Nears FDA Approval
23 Jan
Summary
- A new pill for sleep apnea is seeking FDA approval.
- The drug targets airway dysfunction between brain and throat muscles.
- FDA submission planned for early 2026, with potential approval in 2027.
A new once-nightly pill, AD109, is on the horizon as a potential first medication specifically for obstructive sleep apnea (OSA), a condition affecting approximately 30 million U.S. adults. Developed by Apnimed, a Cambridge, Massachusetts-based company, this drug targets the underlying dysfunction between the brain and throat muscles, aiming to keep the airway more open during sleep.
The medication combines aroxybutynin and atomoxetine to work synergistically, improving breathing and oxygenation overnight. Clinical trials have shown significant reductions in nightly breathing interruptions and improved oxygenation compared to placebos. Frequently reported side effects include dry mouth and insomnia, with no serious adverse events noted.
This innovative treatment represents a potential "holy grail" for sleep researchers, offering an alternative for patients who struggle with traditional CPAP machines. Apnimed plans to submit a new drug application to the FDA in the first half of 2026, with a potential market launch anticipated in early 2027, pending regulatory review.
