An experimental once-daily pill, AD109, has demonstrated a significant reduction in breathing interruptions related to sleep apnea, showing approximately a 44% decrease in a phase 3 trial. This study involved 646 adults who were unable or unwilling to use standard positive airway pressure (PAP) therapy. AD109 was found to improve various nighttime breathing metrics and oxygen levels, although some participants discontinued due to side effects.
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Obstructive sleep apnea (OSA) poses challenges by causing repetitive blockages in the upper airway during sleep, resulting in disrupted breathing and lowered oxygen levels. While continuous positive airway pressure (CPAP) therapy is a common treatment, it is not suitable for all patients, prompting research into alternative solutions.
AD109 combines two medications, aroxybutynin and atomoxetine, intended to enhance upper airway muscle activity during sleep, thus reducing the likelihood of airway collapse. Dr. Patrick John Strollo, a sleep medicine physician at the University of Pittsburgh Medical Center, noted that the lack of treatment options for many patients with OSA is concerning, particularly compared to other chronic diseases.
The phase 3 SynAIRgy trial involved participants who had mild to severe obstructive sleep apnea and had refused or could not tolerate PAP therapy. Participants were randomly assigned to either receive AD109 or a placebo, with neither the researchers nor the participants aware of the treatment allocations. The study, which spanned 26 weeks across 69 sites in the U.S. and Canada, included overnight sleep studies at the trial's onset and conclusion.
Results indicated that those taking AD109 experienced a 44.1% reduction in their apnea-hypopnea index (AHI), compared to a 17.6% reduction in the placebo group. Significant improvements were also noted in indicators of nighttime oxygen levels, with over 40% of participants on AD109 moving to a less severe sleep apnea category. However, there was no statistically significant difference observed in fatigue levels.
Side effects were reported, with the most common being dry mouth, nausea, insomnia, and urinary difficulties. Approximately 21% of AD109 users ceased treatment due to adverse effects, in contrast to about 3% in the placebo group. The findings suggest that AD109 may become an alternative treatment for individuals unable to utilize PAP therapy, though it remains an investigational drug and should not replace existing treatments without further validation.