By Jordan Stern, MD
About the author: Jordan Stern, MD, Founder and CEO of BlueSleep, is a Head and Neck surgeon, a subspecialty of Ear, Nose and Throat (ENT or Otolaryngology), who has treated over 10,000 Sleep Apnea patients and published multiple studies on the diagnosis and treatment of Sleep Apnea. He is also the author of The New York Times bestselling book, Dropping Acid, about reducing acid reflux through a better diet.
Apnimed’s Results Show Real Improvement in Sleep Apnea
A first-of-its-kind oral drug to cure Sleep Apnea is getting closer to FDA approval, bringing tears of joy and the hopeful sound of silence to bed partners and the millions who suffer from Snoring and Sleep Apnea. A Cambridge, Massachusetts-based company called Apnimed has raised $207 million since 2018 to develop a portfolio of novel pharmacological therapies for Sleep Apnea. It’s backed by venture firms like Alpha Wave that have funded Uber, Lyft and Twitter. And, the results are looking promising.
The company reported that its Phase 2 study of the drug currently named AD109 led “to clinically important reduction in AHI in most patients with mild, moderate and severe OSA.” The results showed that the drug “improved daytime fatigue, an often-debilitating effect of poor sleep due to OSA.” The company is now recruiting over 1,200 patients for two Phase 3 trials lasting six months and one year, respectively, to learn more about the safety and efficacy of the drug. The fourth and final phase will then monitor real-world performance after regulatory approval.
Research for Sleep Apnea Treatment is Focused on the Molecular Level
For years scientists have been advancing the causes of sleep disorders. The National Heart, Lung and Blood Institute has made sleep a “critical opportunity” and its #1 target is “molecular and cellular indicators of normal processes, disease processes, and responses to an exposure or intervention (biomarkers) that are critical to translating advances in sleep and circadian science.”
With so much attention to “molecular and cellular indicators”, a large, research-based health system, Johns Hopkins Medicine, identified new treatment potential for Sleep Apnea. In a study with obese mice researchers say they have added to evidence that specialized channel proteins are possible therapeutic targets for sleep apnea and similar abnormally slow breathing disorders in obese people.
Apnimed developed a novel drug that targets neurological pathways. AD109 combines Apnimed’s novel selective antimuscarinic (aroxybutynin) with a selective norepinephrine reuptake inhibitor (atomoxetine), targeting key neurological pathways in OSA that activate upper airway dilator muscles to maintain an open airway during sleep. What this means is that the drug works by targeting the muscles that keep the breathing passages open while asleep.
Apnimed Won’t Eliminate CPAP, Oral Appliance or Inspire Surgery
While Apnimed’s oral drugs may make a dent in the revenues of CPAP and Oral Appliance manufacturers and cause a slide in Inspire's stock price, there will still be a thriving business for traditional devices and surgical treatments. Why? Oral drugs have side effects and not all patients have positive reactions to certain types of drugs. Also, when a new drug receives FDA approval, it does not mean it works for everyone. In many cases, it may only be effective for less than 50% of the subjects in a clinical trial. Still, it means 50% of subjects had a good response.
Furthemore, the Sleep Apnea market is large and growing. There are over 54 million Americans who suffer from Sleep Apnea. Only about 20% seek diagnosis and treatment, mainly because front line healthcare professionals don’t diagnose OSA. They are simply unaware that non-specific symptoms such as fatigue, daytime sleepiness, hypertension and irritability are associated with Sleep Apnea. But, this is changing quickly as the public is becoming more aware of the benefits of sleep health and the risks of Sleep Apnea.
Big insurers will likely exert their power for what types of treatments will be reimbursed. They already require patients to seek non-invasive treatments before paying for surgery. Depending on the cost of the Apnimed medication, they may require patients to try CPAP or an oral appliance before taking an expensive pill.
BlueSleep Welcomes Apnimed’s Innovation in Sleep Apnea Treatment
BlueSleep has always been on the leading edge of diagnosing and treating sleep disorders. We quickly adopted telemedicine during COVID; prescribed Home Sleep Tests for convenience and affordability; and adopted digital face mask technology to improve CPAP fit. We even received a patent for an App to identify patients with Sleep Apnea. As clinical Sleep Specialists, our goal is to get patients the best clinical solution to improve their sleep health.
So, we’re excited about the potential of Apnimed to cure Sleep Apnea patients with a daily pill. When Apnimed launches Phase 4, BlueSleep will gladly provide real-world performance of the drug based on results of pre- and post- treatment home sleep tests. In the meantime, we’re ensuring patients have access to the most advanced diagnostic and treatments for this debilitating disease.
Get an Action Plan for Sleep Apnea
If you’re suffering from daytime sleepiness, snoring, and chronic fatigue, then we recommend the following:
- Make an appointment with a Sleep Specialist.
- Take a Home Sleep Test to measure Sleep Apnea.
- Get a Mandibular Advancement Device (MAD) or CPAP to reduce snoring and prevent Sleep Apnea.
- Take another Home Sleep Test three months after the MAD treatment.
- If you’re overweight, first consider a diet and exercise program.
- Follow-up with your doctor every 12 months to monitor your sleep health
Apnimed’s lead product candidate, AD109, represents a novel pharmacological approach that is specifically designed to target the neurological control and activation of upper airway dilator muscles to maintain an open airway during sleep. If approved, AD109 would be the first medication indicated to address the disordered nighttime breathing that characterizes obstructive sleep apnea.
Combination of atomoxetine with the novel antimuscarinic aroxybutynin improves mild to moderate OSA.
Rosenberg R, Abaluck B, Thein S. J Clin Sleep Med. 2022;18(12):2837-2844.Combination of atomoxetine with the novel antimuscarinic aroxybutynin improves mild to moderate OSA.
Development of a combination of noradrenergic and antimuscarinic drugs for the treatment of obstructive sleep apnea: Challenges and progress.
Taranto-Montemurro L, Pho H and White DP. Front. Sleep 2:1148282.
The Oral Agent AD109 Improves Objective and Subjective Outcomes in Obstructive Sleep Apnea Patients. Results From the MARIPOSA Study, a Randomized, Controlled Clinical Trial.
Schweitzer P, Ojile JM, Thein S, Drake C, Rosenberg R, Corser B, Abaluck B, Sangal RB, Maynard J, MARIPOSA Trial Investigators. In: American Thoracic Society 2023 International Conference. Presented Sunday May 21, 2023, Washington, DC.
The Combination of Aroxybutynin and Atomoxetine in the Treatment of Obstructive Sleep Apnea (MARIPOSA): A Randomized Controlled Trial.
Schweitzer PK, Taranto-Montemurro L, Ojile JM, Thein SG, Drake CL, Rosenberg R, Corser B, Abaluck B, Sangal RB; Maynard J. Epub before print.