Sleep apnea pill could be game-changer for condition afflicting millions

CAMBRIDGE, Mass - It could be a game-changer for the millions of Americans who suffer from sleep apnea. A new first-of-its-kind pill could change the way people treat the condition, which can lead to serious health problems and threatens to significantly shorten life expectancy. 

The treatment could also mean an end to the widely loathed, often uncomfortable and cumbersome mask and hose machine known as Continuous Positive Airway Pressure or CPAP, the most commonly prescribed treatment for obstructive sleep apnea, or OSA.

What we know:

Pharmaceutical company Apnimed said its pill, AD109, is a simple-to-use once-daily oral drug that could "expand and reshape the treatment landscape."

Armed with findings from critical phase 3 clinical trials, the company said within months, it's set to submit the pill for a New Drug Application with the Food and Drug Administration.

The move, which requires clinical trial results to prove the drug’s safety and efficacy, essentially requests permission from the FDA for a license to market the drug. 

How the drug works

The pill is taken at bedtime and works by helping to stabilize breathing disruptions in the upper airway while sleeping, according to the Massachusetts-based company.

Dig deeper:

Obstructive sleep apnea occurs when muscles in the back of the throat relax. 

Those muscles support the back of the roof of the mouth, known as the soft palate and the tissue hanging from the soft palate, called the uvula. The back of the throat muscles also support the tongue, tonsils, and the side walls of the throat, according to the Mayo Clinic's description of OSA. 

During sleep, when those muscles relax, it restricts the upper airway. When a person breathes in, the airway narrows or closes.

"You can't get enough air, which can lower the oxygen level in your blood. Your brain senses your inability to breathe and briefly wakes you so that you can reopen your airway," the Mayo Clinic explained, adding, "This awakening is usually so brief that you don't remember it."

Experts say that often leads to snoring, leaves the person gasping or choking for air. 

"This pattern can repeat itself 5 to 30 times or more each hour, all night, affecting your ability to reach the deep, restful phases of sleep," the Mayo Clinic explained. 

Targeting the root cause:

Apnimed said its pill "is designed to target that underlying neuromuscular dysfunction." 

That’s achieved with a two-thronged approach: one that increases nerve signals to the muscles in the upper airway to help prevent the throat from collapsing while asleep. Another that increases chemicals in the brain to keep the tone of the throat muscles from relaxing too much, allowing for the upper airway to remain open.

"AD109 combines two components: aroxybutynin, a novel antimuscarinic, and atomoxetine, a selective norepinephrine reuptake inhibitor," the company said, adding, "Together, they are designed to work synergistically to help stabilize the upper airway during sleep, improving breathing and oxygenation overnight."

Clinical trials 

Apnimed said its two large phase 3 clinical trials involved a broad range of adult participants who suffered from mild, moderate, and severe OSA.

Compared with placebo, the pill resulted in sharp reductions in hourly breathing interruptions, helped with improving blood oxygen levels, and reduced the severity of the condition, according to the company.

The trials showed people who used the drug saw breathing pauses reduced by about 50% by 26 weeks. 

None of the participants reported any dangerous or severe side effects, Apnimed said. 

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"These studies were designed to include broad, real-world patient populations, reflecting the diversity of people affected by OSA," the company noted. 

Millions suffer from sleep apnea

Sleep apnea affects an estimated 30 million people in the U.S., according to the American Medical Association. 

Some estimates are even significantly higher, suggesting more than 80 million Americans and a billion adults worldwide suffer from the condition which health experts say can be potentially life-threatening if left untreated.

Sleep apnea has been linked to a range of serious health issues like high blood pressure, type 2 diabetes, and heart problems including heart attack and stroke. 

"Untreated OSA is associated with repeated drops in oxygen levels during sleep, which are linked to cardiovascular disease, metabolic complications, cognitive impairment, and reduced quality of life," the company said. 

The effects of the condition, if left untreated, can even lead to shortened lifespan, according to research including a study released last month by the University of Missouri School of Medicine.  

"OSA should be considered a top public health priority: it is a serious, common, chronic disease that affects a wide range of people, impacting both males and females of all age groups, ethnicities, and weight classes, including those with or without obesity," Monica Mallampalli, president and CEO of the Alliance of Sleep Apnea Partners,  was quoted as saying in an Apnimed news release. 

Current treatments

The CPAP, the most widely used treatment for OSA involves a machine hooked up to a hose and includes straps and a mask designed to deliver air through the mouth and nose to keep the airway open during sleep.

Many users find the treatment noisy, uncomfortable, with some saying the mask makes them feel restricted and claustrophobic. Others complain that the many parts of the machine are hard to use, clean and maintain. 

Other treatments include surgical interventions to remove obstruction and permanently increase airflow.

There’s also a pace-maker-like device known as Inspire, which is implanted in the chest. The device monitors breathing and sends "gentle pulses" to keep the airway open by moving the tongue out of the way with each breath, according to the device maker.

What's next:

Apnimed said it's making progress in its plans to submit its New Drug Application to the FDA, which the company is aiming to do in the first half of this year.

"Our focus right now is on completing that process rigorously and responsibly," the drugmaker shared, noting that when the product is available to the public will depend on the FDA review process.

The company said currently, there’s no other oral therapy on the market to treat the condition and its drug would address a highly preventable yet widespread health problem that is severely underdiagnosed and often goes untreated. 

"AD109 is being developed as a potential first-in-class option," Apnimed said, "that could expand treatment choices for people who are diagnosed with OSA but struggle to use or sustain existing therapies." 

This story was reported from Oakland, Calif.