People suffering from sleep apnea may soon have a new path to quality sleep.
A Massachusetts biotech startup is preparing to apply for FDA approval of a once-nightly pill that could be the first drug approved for treatment. Disturbing sleep apnea syndrome (OSA).
Experts say about 30 million adults in the United States suffer from a severe sleep disorder in which breathing stops and starts during the night.
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They are two types of disorders: obstructive sleep apnea (OSA) and central sleep apnea. According to the National Institutes of Health (NIH), the most common type of OSA causes breathing to stop due to a physical obstruction of the airway.
Central sleep apnea occurs when: brain In some cases, health problems prevent the body from sending normal breathing signals.
“People who suffer from OSA wake up briefly because their breathing stops intermittently,” sleep expert Dr. Paul Muchowski, founder and CEO of Defined Sleep in San Francisco, told FOX News Digital. “These arousals disrupt the normal structure of sleep and ultimately lead to a reduction in deep, restorative sleep.”
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Experts say people with the condition often wake up feeling unrefreshed and tired, leading to symptoms such as irritability, difficulty concentrating, poor cognition and memory, and headaches.
“It also increases your risk of heart disease, stroke, and neurodegenerative diseases such as: Alzheimer’s disease and Parkinson’s disease” he added.
According to the Cleveland Clinic, sleep apnea is diagnosed through sleep studies, which use sensors attached to the body to monitor heart, lung and brain activity to assess sleep quality.
“Surprisingly, many people with sleep apnea don’t even know they have it,” Dr. Muchowski noted.
The standard first-line treatment for OSA is a continuous positive airway pressure (CPAP) machine. This uses a mask to deliver pressurized air to keep your airways open while you sleep.
Many people find it bothersome to keep using a CPAP machine, Muchowski said, and as a result, they may not seek treatment even if they are diagnosed with sleep apnea.
In 2024, the FDA will weight loss drugs Zepbound is used to treat moderate to severe OSA, but only in adults who are obese despite a low-calorie diet and increased physical activity.
Dr. Muchowski noted that the drug does not target the underlying cause of OSA and simply reduces weight, which may lead to less sleep problems.
If conservative treatment fails, more invasive options are needed — surgery etc. Removal of enlarged tonsils may be considered, experts say.
ApniMed, a Cambridge, Massachusetts-based pharmaceutical company focused on treating sleep apnea, has developed a drug known as AD109 that is designed as an alternative for patients who cannot tolerate CPAP machines.
Not currently available FDA-approved oral medication The company pointed out that it is particularly indicated for obstructive sleep apnea syndrome.
“A drug to treat sleep apnea has always been a long-sought holy grail for sleep researchers around the world,” said Muchowski, who was not involved in the drug research.
In people with mild, moderate, and severe OSA, AD109 helps keep the airways open during sleep by targeting the underlying dysfunction between the brain and throat muscles, an ApniMed representative told Fox News Digital.
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Once-daily tablets combine: two drugs: Alloxybutynin, which controls muscle signals, and atomoxetine, which increases norepinephrine levels. (According to the Cleveland Clinic, norepinephrine is a hormone and neurotransmitter that helps regulate alertness, alertness, heart rate, blood pressure, and the “fight-or-flight” response.)
“Combined, they are designed to work synergistically to stabilize the upper airway during sleep and improve nighttime breathing and oxygen delivery,” the company added.
In a Phase 3 clinical trial, participants who received the drug significantly reduced their average number of sleeps per hour. interruption of breathing compared to those who took a placebo.
In a phase 3 trial, Participants reduced their nocturnal sleep apnea by an average of 55.6% and also significantly improved oxygenation after 26 weeks.. A second phase 3 trial showed similar results.
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The company said the most frequently reported side effects were dry mouth and insomnia, but no serious adverse events related to AD109 were reported.
“Additional safety details will be included in a future peer-reviewed publication,” they added.
of Research supporting AD109 Muchowski said potential treatments for OSA appear to be “very solid.”
“If this potential treatment is approved by the FDA to treat OSA, tens of millions of people around the world could potentially sleep better and avoid all the negative effects of OSA,” he added.
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ApniMed plans to submit a new drug application to the FDA in the first half of 2026. Although timelines may vary, a standard review typically takes approximately 10 months. This means the pill could hit the market in early 2027.
“Our focus now is to complete that process rigorously and responsibly,” the company said.
