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Medical Daily
Medical Daily
Elena Vega

Sleep Apnea Pill Faces a February Decision After Regulators Questioned Whether Its Main Result Is Meaningful

The first pill submitted to U.S. regulators as a treatment for obstructive sleep apnea now has a decision date. The Food and Drug Administration accepted the application for AD109 and set February 28, 2027, as its target for acting on it.

For the millions of Americans who were prescribed a CPAP machine and could not tolerate it, that date is the one that matters. The drug is a once nightly tablet combining aroxybutynin and atomoxetine, designed to increase muscle tone in the upper airway during sleep rather than force it open with pressurized air.

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