First Pill For Obstructive Sleep Apnea Shows Promise In Phase 3 Study
You could say that it's difficult to mask the challenges that people with obstructive sleep apnea face every day. But if this pill from Apnimed, Inc. eventually gets approved by the U.S. Food and Drug Administration, it could give those OSA sufferers who are having trouble wearing a continuous positive airway pressure mask while sleeping another option. Apnimed recently announced rather eye-opening topline results from the SynAIRgy phase 3 clinical trial of their AD109 pill. A little over half (51.2%) of the study participants who took the once-a-day pill had a reduction in their OSA severity while nearly a quarter (22.3%) experienced achieved complete OSA control.
Obstructive Sleep Apnea Affects A Quarter Of The Adult Population
More options would probably be a welcome possibility for the over 25 million adults in the U.S. who suffer from OSA, based on the National Healthy Sleep Awareness Project. The American Academy of Sleep Medicine has indicated that an estimated 26 percent of adults between the ages of 30 and 70 years have sleep apnea. That may be an underestimate because people are kind of asleep when they are experiencing signs and symptoms of OSA. It could take someone else trying to share a bed with you to tell you that you are snoring or even gasping for breath when you are asleep.
OSA is one type of sleep apnea. Sleep apnea is when you repeatedly stop and start breathing while sleeping. Its important to know if this is happening because breathing is sort of important. Sleep apnea can lead to sleep deprivation, which, in turn, can lead to daytime drowsiness and over the longer term various chronic medical conditions, as I've described previously in Forbes. One such condition is high blood pressure, which in turn can raise the risk of heart disease and stroke.
OSA is when the apnea is due to your throat muscles relaxing too much and blocking your airway. That's why one possible sign of OSA is snoring, which can occur when air tries to pass through the narrowed airway. The following illustration shows what can happen to the airway with OSA:
(Illustration: Getty)
Here Are The Current Treatment Options For Obstructive Sleep Apnea
All of the currently available treatment options for OSA are focused on one thing: keep that airway open as much as possible. Changes in sleep position could help. For example, sleeping on your side, particularly the left side, can keep the airway open better than sleeping on your back. the latter can allow your tongue and soft palate to collapse into your airway.
One oft-mentioned treatment option is the CPAP mask. The name is a clue to what it does. You wear a mask that will continuously will blow air into your nose or nose and mouth. That air is supposed to provide positive pressure to keep your airways open, sort of like blowing air into one of those balloons that can become a balloon animal. Although a variety of such masks are available, wearing such a mask throughout the night may not necessarily be the most pleasant, comfortable or sexy thing.
Another option is some kind of mouthpiece designed to keep the throat open during sleep. Some such devices thrust your lower jaw forward. Other such devices hold your tongue is particular positions.
When OSA gets particularly severe, surgery may be needed. This could be surgery to remove excess tissue in the neck that may be blocking the airway or move forward the jaw bones to give more space behind the tongue and soft palate. Life-threatening cases of OSA may even require a tracheostomy, which is when a hole is made in your throat and a breathing tube is inserted there.
Now you may have heard about one of the glucagon-like peptide-1 receptor agonists, Zepbound, getting FDA-approval for severe OSA. This would be mainly for folks who have OSA due mainly to obesity. Excess fatty tissue in the neck can indeed predispose you to OSA. Therefore, weight loss can be helpful in reducing OSA. However, many people suffer from OSA do not have excess body weight. For many, it's just the anatomy of the airway and the way the nerves happen to be working or not working that allows too much collapse of the airway.
The Apnimed Pill Could Become The First Prescription Pull For Obstructive Sleep Apnea
This brings us to how AD109 is supposed to work. The medication is a combo of 2.5 mg of aroxybutynin, a new type of antimuscarinic, and 75 mg atomoxetine, which inhibits the reuptake of the neurotransmitter norepinephrine, thereby increasing the time it spends in between nerves. These work to increase the nerve signals sent through the hypoglossal motor nucleus that control the muscles in the upper airway.
The medication has already gone through more than 15 Phase 1 and 2 clinical trials. A Phase 2b clinical trial named MARIPOSA showed that those taking AD109 experienced statistically significant reductions in their AHIs. AHI stands for apnea-hypopnea index, a commonly used measure of how severe sleep apnea is. The AHI is the average number of apneas, which are complete pauses in breathing, and hypopneas, which are partial reductions in breathing, that happen per hour of sleep during a sleep study. Normally, this should be less than five. Having five to 14 such events per hour classifies you as having mild sleep apnea. When this goes up to 15 to 29, it's moderate sleep apnea. The severe range is 30 or more such events per hour.
Next up was the SynAIRgy trial, a randomized, double blind, placebo-controlled, parallel-arm of the medication designed to extend for six months. It included 646 adult study participants with OSA who either couldn't tolerate or didn't want to use CPAP. Around half (49.1%) of the study participants were women. At the beginning of the trial, 34.4% had mild OSA, 42.2% moderate and 23.2% severe. Patrick Strollo, Jr., MD, Vice Chair of Medicine for Veteran's Affairs and a Professor of Medicine at the University of Pittsburgh School of Medicine. served as the study chair of SynAIRgy. Strollo described the results so far as 'highly encouraging."
At the 26-week mark in the SynAIRgy trial, those taking AD109 every day had on average a 55.6% reduction in their AHI. As mentioned previously, 51.2% actually dropped in sleep apnea disease severity categories with 22.3% going to the no apnea category, namely less than five events per hour. Those taking AD109 also on average had improvements in the amount of oxygen they were getting into their blood via their lungs. There were also no AD109-related serious adverse events with the medication in general being well-tolerated. Topline results from a second Phase 3 clinical trial, LunAIRo, will probably be available by the third quarter of 2025.
All of this means that the company is currently on track to submit a New Drug Application for AD109 to the FDA by early 2026. If it reaches the market, AD109 would be the first prescription pill specifically for obstructive sleep apnea—which, again, affects quite a lot of people out there, probably much more than people realize. So don't sleep on what happens next.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
an hour ago
- Yahoo
Researchers issue warning after discovering game fish infected with parasite in California: 'These parasites are here in the US'
If you're eating freshwater fish in Southern California, you'll want to take extra precautions since fish have become infected with parasites. A study by the University of California, San Diego found that over 90% of game fish studied had been infected with a parasite. The study, published in the Journal of Infectious Diseases, found "two species of [parasitic] flatworms called trematodes," which typically cause weight loss, lethargy, or gastrointestinal problems when humans get infected. In rare cases, it can cause heart attacks or strokes. Haplorchis pumilio and Centrocestus formosanus were the "two species of parasitic trematodes," identified, per UC San Diego. These parasites are typically found in Southeast Asia, but it is likely that an aquatic invasive snail, known as the Malaysian trumpet snail or red-rimmed melania, brought them to the U.S. over 10 years ago. The researchers examined 84 different species of fish in 2023 from five fishing sites in San Diego County, including bluegill and largemouth; 93% were infected with the Haplorchis pumilio parasite, and "Centrocestus formosanus, was found at two of the five locations where it occurred in 91% of the fish," per UC San Diego. UC San Diego's Scripps Institution of Oceanography ecologist and parasitologist, and senior author of the study, Ryan Hechinger, said, "These parasites are here in the U.S., and they're infecting fish that people are eating." These parasites, which are appearing in freshwater fish, serve as an example of why invasive species can be dangerous. While not all non-native species are harmful, those that are can cause damage to the ecosystem and pose health risks, as in this case. The Asian tiger mosquito is another invasive species that can carry disease. It entered the U.S. in the mid-1980s, and some harbored the West Nile virus. The mosquito also invaded Europe in 2024, carrying the dengue fever virus. Invasive species also wreak havoc on the economy, causing damage to crops, livestock, and fish, costing the U.S. $20 billion a year for cleanup. Additionally, they are harmful to the environment because they take resources from native species, sometimes causing them to go extinct. How often do you worry about the quality of your drinking water? Never Sometimes Often Always Click your choice to see results and speak your mind. Hechinger said there is "no need to panic," because you can thoroughly cook or freeze your fish "for at least one week" to kill the parasites, if you plan to eat it raw, per Food and Drug Administration guidelines, as reported by UC San Diego. There have been no reported cases yet, but researchers want the parasite to be added to the diseases that public health officials are required to report. Hechinger said, "This kind of research is so important to identifying new public health threats, and it wouldn't have been possible without NIH funding." Invasive species such as this aquatic snail that is spreading parasites are one of the critical climate issues that are vital to understand to protect the public from these threats. Join our free newsletter for good news and useful tips, and don't miss this cool list of easy ways to help yourself while helping the planet.
Yahoo
an hour ago
- Yahoo
13 Compliments That Make You Sound Fake (Even If You Meant Well)
In the art of giving compliments, intention is everything—but execution is key. In trying to make someone feel good, we sometimes stumble into the realm of the insincere, uttering phrases that, though meant to uplift, end up sounding as authentic as a plastic plant. While you may be well-meaning, certain compliments can come off as hollow or disingenuous, inadvertently leaving the recipient more bewildered than buoyed. Let's delve into these conversational landmines and why they might need a rethink. At first glance, this may seem like a straightforward compliment. However, focusing solely on weight loss can unintentionally highlight prior insecurities about one's body or imply that they were less worthy before the transformation. According to Dr. Rebecca Puhl, a leading researcher at the Rudd Center for Food Policy & Obesity, comments on appearance can often reinforce societal pressures and stigmatization. Instead, celebrate their overall well-being or increased energy, which acknowledges their efforts without reducing their value to a number on the scale. Moreover, this compliment assumes that weight loss is always positive, which isn't universally true. It's crucial to consider that the context, health issues, and stress can also result in weight fluctuations. By focusing on appearance, you risk perpetuating a shallow value system where external changes are prioritized over inner growth. It's far more meaningful to appreciate the person holistically, valuing their journey beyond the obvious. While age-related compliments can seem flattering, they often feel patronizing or dismissive. The underlying message is that looking younger is preferable, inadvertently devaluing the wisdom and experiences that come with age. This can cause the person to question if their worth diminishes as they grow older, reducing a lifetime of experiences to a mere number. Celebrating their accomplishments or tenacity instead pays homage to the person they've become, not just how they appear. In addition, these comments often reinforce societal standards that idolize youth over maturity and experience. By placing so much emphasis on age, you risk trivializing the journey and achievements that come with time. Opt for respect over flattery—appreciate their insights, their stories, and their continued growth. It's a genuine recognition that transcends the superficial and honors the richness of their life. At first, this might seem like admiration but dig a little deeper, and it can feel more like a backhanded compliment. The implication is that their style choice is so daring or unconventional that it requires courage to pull off, suggesting it might be outlandish or inappropriate. Professor Jennifer Thomas of Psychology Today points out that genuine compliments should empower rather than patronize, allowing the individual to feel celebrated rather than scrutinized. Instead, focus on what you genuinely admire about their style without framing it as an act of bravery. The word "brave" can carry the unintended weight of judgment, subtly communicating that their choice deviates from the norm. This can make the recipient feel as though their personal expression is somehow audacious or extreme. Instead, express admiration for their confidence or creativity, highlighting what you truly appreciate about their unique style. It shifts the focus from a potentially negative connotation to one of respect and positivity. This compliment is a classic case of damning with faint praise. It offers a compliment at the expense of an insult, suggesting that the person's appearance doesn't align with intelligence. Such comments perpetuate stereotypes about what smart should "look" like, often marginalizing those who don't fit into conventional molds. It's far more impactful to appreciate their intellect directly and without qualifiers. The presumption that intelligence has a physical manifestation is not only outdated but also offensive. It diminishes a person's achievements by insinuating they're contrary to expectations based on looks. Such stereotypes are deeply entrenched in societal biases, and breaking away from them requires conscious effort. Celebrate their intellect by recognizing specific contributions or insights, offering a meaningful acknowledgment that resonates with their true self. This compliment, though often intended as high praise, can come across as both divisive and reductive. By singling someone out as better than their demographic, you inadvertently uphold stereotypes about their group. Research conducted by Dr. Derald Wing Sue highlights the subtle biases that perpetuate through seemingly positive remarks, often referred to as microaggressions. A more inclusive and considerate approach is to appreciate the individual's qualities without drawing unfavorable comparisons. The risk here is alienation, implying that there's something inherently undesirable about the group as a whole. This can lead to feelings of isolation or betrayal among their peers and undermine the diversity within the group itself. Instead, focus on the individual's unique traits or achievements, celebrating their personal attributes without negating the value of their community. Authentic appreciation recognizes diversity as a strength, not a shortcoming. Acknowledging humility is commendable, but this compliment can sometimes feel like a veiled expectation. It can imply that any display of pride or self-confidence would be uncharacteristic or unwelcome. The compliment, if overused or misapplied, pressures individuals to downplay their achievements to maintain a facade of modesty. Instead, appreciate their accomplishments directly, reinforcing their right to own their successes. Being labeled as humble can also create an expectation that one should consistently downplay their own worth and achievements. It may unintentionally pressure people into a corner where they feel unable to assert themselves or accept deserved recognition. Instead of boxing them into a stereotype, celebrate their achievements with enthusiasm, encouraging them to relish in their successes. Genuine appreciation means acknowledging the full spectrum of their personality, including both humility and pride. Intended as a nod to someone's boldness or creativity, this phrase can feel more like self-criticism than appreciation. It suggests that their choice is so far out of the ordinary that it would be impossible for anyone else to replicate it successfully. Psychologist Dr. Susan Krauss Whitbourne argues that proper compliments should enhance someone's self-esteem without undercutting one's own. Instead, try expressing admiration for their confidence or the thoughtfulness behind their choices. This type of compliment can also imply that the person's style is somehow inaccessible or requires a specific kind of person to carry it off. It puts the emphasis on the rarity of their choice rather than the beauty or originality of it. By acknowledging their taste or the skill involved in putting together their look, you offer a more genuine appreciation. It fosters an environment where personal style is celebrated and shared rather than set apart as an anomaly. Though often intended as flattery, this compliment implies that the person's age should typically yield less favorable results. It reinforces the notion that aging is inherently undesirable, rather than a natural and dignified process. By suggesting that looking good at a certain age is an exception rather than the norm, you might inadvertently contribute to ageism. Instead, validate their vitality and presence without tying it to age. Equating attractiveness with age can inadvertently send the message that one's worth is diminishing over time. Such comments perpetuate the fetishization of youth and overlook the grace and beauty that mature individuals possess. Instead, celebrate their energy, their vibrancy, or a specific aspect that truly stands out. Appreciation rooted in genuine admiration holds more value than one tethered to age-related expectations. Being nice is undoubtedly a positive trait, but as a compliment, it can feel bland and non-specific. It's often used as a default remark when nothing more insightful comes to mind, lacking depth or genuine reflection. The ambiguity leaves the recipient with little sense of what aspect of their personality is being appreciated. Instead, pinpoint what makes their kindness stand out—whether it's their generosity, their listening skills, or their genuine interest in others. In a world that values authenticity and individuality, being labeled simply as "nice" can feel reductive. It overlooks the unique characteristics that make a person genuinely kind or thoughtful. Complimenting someone's specific actions or the impact they've had on others offers a more meaningful acknowledgment. It shifts the compliment from a vague nicety to a heartfelt recognition of their positive influence. While this might seem like the ultimate compliment, it's inherently overwhelming and unrealistic. Perfection is an unattainable standard that can place undue pressure on the recipient to maintain an illusion of flawlessness. This can lead to unnecessary stress or anxiety, as no one is perfect, and striving for such can be damaging. Instead, celebrate their qualities that make them uniquely wonderful without imposing impossible standards. The notion of perfection doesn't allow room for growth, learning, or the natural human experience of making mistakes. It's the imperfections that create character and depth, and they deserve acknowledgment just as much as the virtues. By appreciating someone for who they are, with all their quirks and facets, you offer a more inclusive and genuine compliment. This encourages an environment where authenticity is valued over unattainable ideals. Attributing someone's success or situation solely to luck can undermine the hard work and dedication that often contribute to their achievements. It implies that their circumstances are a result of chance rather than effort, skill, or perseverance. Such comments can minimize the personal sacrifices or challenges they've faced along the way. Instead, recognize the dedication or strategic choices that led them to their current status. Luck certainly plays a role in life, but it's rarely the whole story. By focusing on luck, the compliment glosses over the complexities and nuances that contribute to success. Recognizing the individual's efforts or talents provides a more robust and respectful acknowledgment of their journey. It's about appreciating the path they've carved rather than attributing it to a roll of the dice. Though intended as a testament to one's outstanding character, this compliment can feel more isolating than uplifting. It suggests that their goodness is so rare that they don't belong, which can lead to feelings of alienation or loneliness. Such words, though poetic, can undervalue the very real struggles and triumphs they navigate daily. Instead, celebrate their positive impact on the world, reinforcing their connection to it rather than distancing them from it. This type of compliment sets an unrealistic pedestal, implying that their virtue is an anomaly in the human experience. It risks placing them in a separate category, disconnected from the everyday reality of others. Instead, focus on how their actions inspire or uplift those around them, grounding their goodness in real-world impact. It places them within the fabric of the community, emphasizing their integral role rather than romanticizing their isolation. While this compliment may come from a place of admiration, it often conveys more envy than appreciation. It suggests that the other person's achievements or qualities are unattainable for you, which can create a divide rather than a connection. Envy, even when framed positively, can lead to feelings of inadequacy or resentment. Instead, express what specifically inspires you about them, offering genuine appreciation without the undercurrent of rivalry. Envy can overshadow the authentic admiration you feel, turning a compliment into a tacit admission of self-doubt. By focusing on jealousy, you inadvertently create a hierarchy where the other person is placed above rather than alongside you. Acknowledging their inspiring attributes fosters a more positive and collaborative relationship. Celebrate their strengths in a way that unites rather than divides, finding common ground in admiration rather than competition.
Yahoo
an hour ago
- Yahoo
Foundation for Sarcoidosis Research Announces Launch of Enhanced Sarcoidosis Data Registry
CHICAGO, July 01, 2025 (GLOBE NEWSWIRE) -- The Foundation for Sarcoidosis Research (FSR), the leading international organization dedicated to finding a cure for sarcoidosis and improving care for those affected, is proud to announce the launch of a new and enhanced version of the FSR-SARC Registry, the Sarcoidosis Advanced Registry for Cures. The FSR-SARC Registry is an IRB-approved, longitudinal, patient-powered database designed to accelerate sarcoidosis research by collecting critical insights on diagnosis, organ manifestation, treatments, symptoms, and impacts on quality of life. With nearly 7,000 participants from 68 different countries to date, the Registry is a cornerstone of FSR's mission to advance understanding and treatment of this complex and often misunderstood disease. The upgraded FSR-SARC Registry introduces a new, user-friendly platform (in partnership with Across Healthcare) with expanded features to maximize the impact of patient participation. Participants can now more easily share their experiences, update their information, and contribute to a growing body of knowledge that supports both clinical research and improved patient outcomes. Key Features and Benefits of the New FSR-SARC Registry: Enhanced Data Collection: The registry now captures even more comprehensive information on patients impacted by sarcoidosis. In addition to questionnaires and surveys, participants receiving care in the U.S. can link the Registry directly to their provider's patient portal. Improved Security and Privacy: Hosted on Across Healthcare's HIPAA-compliant platform, the Registry ensures that all personal health information is encrypted, securely stored, and only shared in de-identified form with approved researchers. Empowering Patient Voices: By enabling patients and caregivers to self-report their experiences, the registry provides critical insights into the variability, progression, and burden of sarcoidosis, informing future research and care recommendations. Facilitating Research and Clinical Trials: The registry connects interested patients to IRB-approved research opportunities based on both their eligibility and proximity to trial sites, helping to stimulate hypothesis-driven research and support the development of new treatments. Commitment to Representation and Access: FSR remains dedicated to expanding the variety of Registry participants and ensuring representation of all sarcoidosis patients. 'FSR is committed to empowering patients and accelerating research through the FSR-SARC Registry. We are immensely grateful for the extraordinary commitment of the sarcoidosis community in giving of their time and insights to inform and drive sarcoidosis research,' said Mary McGowan, President and CEO of FSR. 'Now in its tenth year, the Registry has been one of our most powerful tools to elevate patient voices in the advancement of sarcoidosis research. The enhanced surveys and platform represent a significant step forward in our efforts to drive innovation elevate patient-centered drug development, and improve patient outcomes for all impacted by sarcoidosis.' Participation in the FSR-SARC Registry is voluntary, confidential, and open to all individuals living with sarcoidosis or their caregivers. By joining, participants help shape the future of sarcoidosis research and care. For more information about the FSR-SARC Registry and to sign up, please visit About Sarcoidosis Sarcoidosis is a rare inflammatory disease characterized by granulomas—tiny clumps of inflammatory cells—that can form in one or more organs. 90% of patients living with sarcoidosis have lung involvement. Despite advances in research, sarcoidosis remains challenging to diagnose, with limited treatment options and no known cure. Approximately 175,000 people live with sarcoidosis in the United States. About the Foundation for Sarcoidosis Research The Foundation for Sarcoidosis Research (FSR) is the leading international organization dedicated to finding a cure for sarcoidosis and improving care for those living with the disease through research, education, and support. For more information about FSR and its community programs, visit: Media Contact: Cathi Davis, Director of Communications and Marketing Foundation for Sarcoidosis Research cathi@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
