Nearly a billion individuals around the globe deal with sleep apnea. This, of course, doesn’t even factor in those who share a bed with them.
Obstructive sleep apnea is characterized by repeated blockages in breathing during sleep, which can lead to daytime exhaustion, headaches, and loud snoring.
Over time, these episodes—where patients struggle to breathe—can seriously affect their heart health, brain function, and other important aspects of well-being.
Now, following a successful phase 3 clinical trial, it appears that a much-needed medication could soon be available in stores, provided it gets the green light from the US regulatory body.
Many individuals suffering from obstructive sleep apnea rely on CPAP machines to keep their airways open during the night.
However, while these machines are quite effective, they’re not always the most comfortable or travel-friendly options. A lot of patients end up abandoning them due to their inconvenience and discomfort.
Patrick John Strollo, a sleep medicine doctor at the University of Pittsburgh Medical Center, points out that most diagnosed patients either remain untreated or receive insufficient treatment.
He mentions, “An oral pill that targets the underlying neuromuscular causes of airway collapse during sleep could help close this treatment gap and expand effective options for those who are currently untreated.”
Strollo and his team have demonstrated the potential effectiveness of such a pill through a phase 3 clinical trial for a medication called AD109, which is taken at night.
They involved 646 patients from the US and Canada diagnosed with mild to severe obstructive sleep apnea who weren’t able to tolerate or chose not to use a CPAP machine.
Participants were randomly assigned to receive either the medication AD109 or a placebo, without knowing which one they were taking.
They took the pill nightly over 26 weeks, beginning with a half-dose in the first week. By week 26, Strollo and his team anticipated that the AD109 group would show notable improvements.
Success was gauged by the apnea-hypopnea index (AHI), a standard measure of obstructive sleep apnea severity.
This index combines the average number of breathing pauses (apneas) and instances of reduced breathing (hypopneas) experienced during sleep.
For those taking AD109, their AHI dropped by about 44% throughout the trial, while the placebo group saw a decrease of roughly 18% on average.
By the end of the study, nearly 42% of those on the medication had moved to a lower severity category, with almost 18% no longer experiencing obstructive sleep apnea at all.
Participants reported just a few mild side effects, such as dry mouth and nausea, which were expected since the components of the drug are well known and used for other treatments.
The medication works by combining aroxybutynin, which reduces activation of the parasympathetic nervous system, and atomoxetine, commonly used for ADHD.
A review of the drug’s mechanism indicates that this combination aims to counteract the reduction of excitatory noradrenergic drive during sleep and inhibition related to REM at the hypoglossal motor nucleus.
Put simply, it helps prevent the upper airway muscles from relaxing too much during sleep.
The US Food and Drug Administration has fast-tracked the approval process for AD109, with a decision expected in 2027.
This isn’t the only CPAP alternative in development, either.
Another recent trial has shown promise in repurposing epilepsy medication, and GLP-1 drugs have been effective for patients whose apnea is linked to obesity.
On the more experimental side, researchers have tested a technique involving implanted electrodes in the tongue and even theorize that activities like blowing on a conch shell could help strengthen the necessary muscles.
Pharmaceutical options, like AD109, could offer a convenient alternative for those looking to escape the hassle of CPAP machines.
“These results provide encouraging evidence that targeting neuromuscular dysfunction can lead to significant clinical improvements, reflecting our increasing understanding of the underlying biology of the disease,” Strollo mentions.
The findings were published in the American Journal of Respiratory and Critical Care Medicine.
