FDA Broadens Access to Over-the-Counter Naloxone Nasal Spray for Opioid Overdose

 

The U.S. Food and Drug Administration (FDA) today approved another over-the-counter (OTC) intranasal naloxone product, Rextovy, a 4 milligram (mg) naloxone hydrochloride nasal spray for the emergency treatment of opioid overdose. Consumers may directly purchase this product without a prescription in places such as pharmacies, convenience stores, and online. This action aligns with President Trump’s Great American Recovery Initiative, a federal effort to address the U.S.’ addiction and substance use disorder crisis and coordinate the government's approach to prevention, treatment, and long-term recovery.  

“Reducing opioid overdose deaths is a top priority for FDA,” said Mike Davis M.D., Ph.D., Acting Director of the Center for Drug Evaluation and Research (CDER). “Today’s approval of an additional over-the-counter naloxone nasal spray helps broaden access and offers an additional option for consumers. Empowering people without medical training to take immediate action with these products has been proven to save lives.”  

Naloxone is a medication that rapidly reverses the effects of opioid overdose and is the standard treatment for opioid overdose. Rextovy is an additional life-saving medication approved by the FDA to reverse an opioid overdose to be sold directly to consumers and contains the same active ingredient as other naloxone nasal sprays. The availability of multiple approved formulations expands access and market availability, encourages competition that may reduce cost, and offers alternative sourcing options.

The number of overdose deaths has dramatically decreased since the first FDA approval of an OTC naloxone nasal spray in 2023, but drug overdose persists as a major public health issue in the U.S., primarily driven by synthetic opioids like illicit fentanyl. In the 12-month period ending in August 2023, 111,451 overdose deaths were reported; in the 12-month period ending in December 2025, 68,632 overdose deaths were reported.¹

“Immediate access to naloxone nasal sprays is essential when a person is experiencing an overdose, and FDA remains committed to ensuring nonprescription options are widely available,” said Karen Murry, M.D., Director of the Office of Nonprescription Drug Products in CDER. “We are proud of the dedicated work our review divisions put into making this approval possible, and we encourage any manufacturer seeking to market a nonprescription naloxone product to contact the agency to initiate a conversation.”

When using Rextovy, some people may experience symptoms when they regain consciousness following overdose reversal, such as shaking, sweating, nausea, or feeling angry. The product is safe to use even when it is uncertain whether opioids are present in the person’s system. The product’s packaging includes pictorial directions with five clear steps, including calling 911 after giving the first dose.

The FDA granted the nonprescription approval to Amphastar Pharmaceuticals, Inc.

¹ Products - Vital Statistics Rapid Release - Provisional Drug Overdose Data

Home blood pressure tests could prevent heart attack and stroke

 

Allowing patients to measure and record their blood pressure at home has been linked to a drop in the risk of cardiovascular diseases, such as heart attack and stroke, a major study shows.  

Patients who were able to self-monitor their blood pressure, with the data shared directly with doctors, had a significantly lower risk of hospitalisation and death than those who received standard care. 

Use of the so-called digital telemonitoring system – which also sends reminders when it is time to take a reading – could help to improve the health of patients, save lives and ease pressure on the NHS, experts say. 

High blood pressure, or hypertension, is a major global health problem, leading to an estimated 7.5 million deaths each year. Lifestyle changes and medicines designed to lower blood pressure can help to manage the condition. Hypertension rarely causes symptoms, so patients require long-term monitoring. 

Previous studies have found that telemonitoring leads to improved blood pressure control, but there has been limited evidence of the long-term impact, including on serious outcomes such as stroke and heart failure. 

Scientists from Edinburgh Napier University and the University of Edinburgh studied almost 450,000 patients across Scotland with hypertension between 2019 and 2022. 9,500 patients used a telemonitoring service, Connect Me BP, while the remaining patients received standard care and were monitored by their local GP. 

Those who took part in the telemonitoring service saw a reduction in their blood pressure within the first three months, which was maintained over a year. They also experienced a significant reduction in cardiovascular outcomes, hospitalisations and deaths, compared with patients receiving standard care.  

The research team caution that although their analysis took account of differences between telemonitoring users and the wider group that might put them at lower risk of a cardiovascular event – such as younger age, requiring fewer medications for their blood pressure, and being less socio-economically deprived – there may have been unaccounted for differences which influenced the findings. 

Further research is needed to investigate the impact of additional risk factors and to explore whether it would be beneficial to extend telemonitoring to a wider demographic and higher-risk group of people with hypertension, they suggest. 

Scotland is now leading the world in deployment of the technology, with 130,000 people having used the Connect Me BP service for both diagnosis and control of blood pressure, experts say. 

The study, funded by the British Heart Foundation, is published in the journal European Heart Journal – Digital Health: https://academic.oup.com/ehjdh/article/7/5/ztag069/8694666#563981228  

Janet Hanley, lead author and Associate Professor in the Cardiovascular Health Research Centre at Edinburgh Napier University, said: “Stroke, heart attack and heart failure are major causes of death and disability and anything which reduces the risk is worthwhile. Blood pressure telemonitoring does this by helping people improve their blood pressure control and is easy and convenient to use.” 

Professor Brian McKinstry, from the University of Edinburgh’s Usher Institute, said: “This study provides the strongest evidence to date that telemonitoring not only reduces blood pressure but strokes and heart attacks too. It is important that we enable people from the most socio-economically deprived parts of the country who are most at risk of these conditions to benefit from it.” 

Professor James Leiper, Director of Research at the British Heart Foundation, said: “High blood pressure raises your risk of having a heart attack and stroke, and once people are diagnosed, they must be monitored closely to ensure it is being effectively treated. 

“This study is further evidence that empowering people to check their blood pressure regularly at home, and send their results to a doctor, with regular reminders to do so, is an efficient approach that could help improve people’s blood pressure control. 

“The reduction in the risk of hospitalisations and deaths from serious cardiovascular events seen in this study is encouraging. Innovative approaches like these could help people to live well for longer.” 

ADULTS W/PREDIABETES: LIFESTYLE INTERVENTION LOWERED MULTIPLE RISKS

 

NIH-supported, long-term clinical trial found no difference between metformin and placebo. 
 
A clinical trial supported by the National Institutes of Health (NIH) found that adults with prediabetes assigned to a lifestyle intervention had a significantly lower risk of developing multiple chronic health conditions (known as multimorbidity) over time than those assigned to a placebo. This study, which followed participants for over two decades, also found that participants assigned to receive metformin did not experience a statistically significant reduction in multimorbidity risk. The findings, published in JAMA, highlight the lasting benefits of lifestyle programs that may lower risk of the development of chronic conditions. 
 
“Multimorbidity is a common issue, and few interventions have been found to prevent or delay developing multiple chronic conditions,” said Marcel Salive, M.D., first author of the study, from NIH’s National Institute on Aging (NIA). “Our work showing that healthy lifestyle intervention can significantly lower the burden of multimorbidity is a step forward in addressing this growing problem.” 
 
Previous research has shown that both metformin and lifestyle interventions have been successful in preventing or delaying diabetes and metabolic syndrome, but the researchers in this study wanted to determine whether these interventions could prevent or delay multimorbidity in addition to diabetes. The clinical trial was conducted in 27 sites in the U.S. and followed 1,173 participants who were at high risk of diabetes, were enrolled in Medicare, and consented to the linkage of their Centers for Medicare & Medicaid (CMS) claims. In the first part of the study, the NIH Diabetes Prevention Program (DPP), from 1996 to 1999, participants were randomly assigned to an intensive lifestyle intervention, metformin (a drug commonly used in the management of Type 2 diabetes), or placebo. They were then enrolled in the DPP Outcomes Study (DPPOS) and followed through 2021. 
 
In the first part of the study, lifestyle participants were offered 16 individual sessions of interventions followed by monthly sessions for approximately two years. The behavior change program targeted reduced calories and fat and at least 150 minutes of physical activity a week to achieve greater than or equal to 7% weight loss from baseline. After DPP trial completion, all participants were offered the intensive lifestyle curriculum in groups during a six-month bridge period. During the outcomes study portion, all participants were offered quarterly group lifestyle sessions, and the original lifestyle participants received booster sessions twice annually. 
 
By the end of follow-up, the researchers found that 85% of the study participants experienced two or more chronic conditions, with 82%, 85%, and 87% experiencing multimorbidity among lifestyle, metformin, and placebo groups, respectively. Compared with the placebo group, participants in the lifestyle intervention had 21% lower risk for two chronic conditions and 25% lower risk for three chronic conditions. Participants assigned to metformin did not experience a statistically significant reduction in risk for multimorbidity. The study examined 15 chronic conditions commonly tracked in Medicare data, including hypertension, heart disease, stroke, arthritis, chronic kidney disease, COPD, cancer, depression, dementia, osteoporosis, and diabetes. These results persisted even when diabetes was taken out of the multimorbidity definition.  
 
“These findings are highly encouraging, reinforcing that lifestyle programs focused on diet and exercise may persistently lower the risk of developing multiple chronic conditions, beyond diabetes,” said Griffin P. Rodgers, M.D., Director of NIH’s National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). “Furthermore, because lifestyle modifications can be safe and cost-effective, sustaining these healthy behaviors among people at risk of diabetes may help reduce not only the individual health burden, but also broader healthcare spending.” 
 

Effective use of hearing aids may help reduce dementia risk in older adults

 

Peer-Reviewed Publication

The University of Hong Kong

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The study led by Professor Chen Shanquan finds that effective use of hearing aids may help reduce dementia risk in older adults.

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Credit: The University of Hong Kong

The School of Public Health at the LKS Faculty of Medicine, the University of Hong Kong (HKUMed), together with a multinational team, has found that the effective use of hearing aids is associated with a lower risk of probable dementia among older adults with hearing loss. The findings highlight the importance of quality hearing rehabilitation for healthy ageing and were published in Cell Reports Medicine [link to the publication].

Dementia is projected to affect 150 million people worldwide by 2050, placing a significant burden on healthcare systems and societies. Hearing loss, a common condition affecting approximately 30% of people over 65 and up to 90% of those aged 85 and older, has emerged as one of the most important potentially modifiable risk factors for dementia.

According to the 2024 Lancet Commission, hearing loss accounts for approximately 7% of dementia cases, making it a leading modifiable risk factor. Professor Chen Shanquan, Assistant Professor in the School of Public Health, HKUMed, and joint last author of the study, said, ‘While hearing aids are widely regarded as the standard first-line treatment for adult hearing loss, their role in preventing cognitive decline has remained uncertain.’

Effective hearing aids linked to 14% lower dementia risk
The study analysed data from 61,089 hearing-impaired adults aged 55 and older, drawn from seven ageing cohorts across 33 countries, including China, Korea, Europe, the UK, the US, Ireland and Mexico. Over an average follow-up period of 6.5 years, 8,911 participants developed probable dementia.

The study found that hearing aid users had a 9% lower risk of probable dementia compared to hearing-impaired non-users. Importantly, the benefit appeared to depend on the effectiveness of the devices. Participants who reported good hearing improvement with hearing aids had a 14% lower risk of probable dementia, whereas those who reported poor hearing improvement showed no significant reduction in risk.

The association appeared stronger in middle-income countries, where hearing aid adoption was substantially lower. Only 2.6% of hearing-impaired participants in these countries reported using a hearing aid, compared with 20% in high-income countries. Together, these findings suggest that improving both access to hearing aids and the quality of hearing rehabilitation should be key public health priorities.

Prioritising hearing care for at-risk groups
The study also found that the association between hearing aid use and lower dementia risk was more pronounced among women, unmarried individuals and those with lower educational attainment. This suggests that hearing rehabilitation may be particularly important for socially vulnerable groups, who may face a higher risk of isolation or reduced access to health resources.

Building on these findings, the researchers have called for future research using objective hearing assessments, real-world device-use data, and more representative samples from low-resource settings. They also recommend that hearing care should be better integrated into dementia prevention, primary care, and healthy-ageing strategies.

The researchers emphasised that the study was observational and cannot prove that hearing aids directly prevent dementia. Nevertheless, the results provide large-scale, multi-country evidence that effective hearing rehabilitation may be linked to better cognitive ageing outcomes.

Bridging gaps in hearing care across regions
Professor Chen Shanquan said, ‘Hearing loss is increasingly recognised as one of the most important risk factors for dementia that can potentially be addressed. Our study suggests that the benefit is not simply about wearing a device, but whether the device meaningfully improves hearing in daily life.’

‘These findings have important implications for healthy ageing policies,’ Professor Chen added. In high-income settings, the priority may be on fitting improvement, follow-up care and the long-term effectiveness of hearing aids. In middle-income settings, however, expanding affordable access to hearing care remains a major challenge.’  

Less than 10% of Americans eat the minimum recommended amount of fiber

 Fiber is well known to be an important part of a healthy diet, yet less than 10% of Americans eat the minimum recommended amount. A new study from Stanford Medicine might finally convince us to fill our plates with beans, nuts, cruciferous veggies, avocados and other fiber-rich foods. The research, which will be published in Nature Metabolism on Jan. 9 identified the direct epigenetic effects of two common byproducts of fiber digestion and found that some of the alterations in gene expression had anti-cancer actions.

When we eat fiber, the gut microbiome produces short-chain fatty acids. These compounds are more than just an energy source for us: They have long been suspected to indirectly affect gene function. The researchers traced how the two most common short-chain fatty acids in our gut, propionate and butyrate, altered gene expression in healthy human cells, in treated and untreated human colon cancer cells, and in mouse intestines. They found direct epigenetic changes at specific genes that regulate cell proliferation and differentiation, along with apoptosis, or pre-programmed cell death processes — all of which are important for disrupting or controlling the unchecked cell growth that underlies cancer.

“We found a direct link between eating fiber and modulation of gene function that has anti-cancer effects, and we think this is likely a global mechanism because the short-chain fatty acids that result from fiber digestion can travel all over the body,” said Michael Snyder, PhD, Stanford W. Ascherman, MD, FACS Professor in Genetics. “It is generally the case that people’s diet is very fiber poor, and that means their microbiome is not being fed properly and cannot make as many short-chain fatty acids as it should. This is not doing our health any favors.”

Given the worrying rates of colon cancer in younger adults, the study findings could also spur conversation and research about the possible synergistic effects of diet and cancer treatment.

“By identifying the gene targets of these important molecules we can understand how fiber exerts its beneficial effects and what goes wrong during cancer,” Snyder added.

 

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Journal

Nature Metabolism

DOI

10.1038/s42255-024-01191-9 

Four minutes of daily resistance training can quadruple fitness in older adults

 

 Just four minutes of daily strengthening exercise dramatically increases key factors in quality of life for aging adults, according to a new study led by researchers at Penn State College of Medicine. Results published in PLOS One showed that strength — which impacts fall risk, longevity, independent living and more — significantly improved for adults aged 65 and older in as little as 12 weeks.

Mobility, or physical fitness, is a critical indicator of quality of life for adults ages 65 and above, allowing for completion of daily tasks and movement. Unintentional injuries such as tripping or falling are among the top leading causes of death among adults ages 65 and over, according to the Centers for Disease Control and Prevention. A lack of physical fitness in aging persists because people believe that they can only reap the benefits of exercise with more extensive resistance training workouts — but that’s not the case, according to lead author Christopher Sciamanna, professor of medicine and of public health at Penn State College of Medicine. He said a short four-minute workout is enough to improve upon several factors of critical mobility indicators.

“The human body is designed to improve very quickly,” Sciamanna said. “And just a few repetitions of an exercise performed regularly can lead to huge improvements. Exercise is about forward thinking — think about what you want to be able to do and train for it.”

While resistance training can greatly increase strength in just a few months, less than one in five older adults exercise for the recommended two days per week of muscle-strengthening activity, partially due to routine length, pain and other limitations.

“Exercise is actually really complicated, because you have to decide how many repetitions, how far, how many sets, how much rest and how many times per week,” said co-author Smita Dandekar, associate professor of pediatrics at Penn State College of Medicine. “It's hard work, so there's huge problems with people wanting to do exercise. If we can make it short, we’re part way there.”

Previously, the team had conducted a study called FAST (Functional Activity Strength Training)-1, a smaller scale experiment where 24 older adults performed 30 seconds of push-ups and squats daily, resulting in improved squat performance over six months. Other studies have also shown that a few sets of exercise per week can lead to nearly the same improvements as longer-length routines. Building off of those findings, Sciamanna’s team decided to test the efficacy of a shorter routine.

In the current study, researchers from Penn Statue tested the effects of a program, called FAST-2, to see if it improved mobility and physical capability in adults older than 65. A total of 97 participants with an average age of 74 years old were randomly assigned to receive either the exercise regimen treatment or no intervention. Prior to the study, participants reported performing an average of about 18 minutes of total exercise each week, which is much lower than the recommended amount of at least 150 minutes moderate or 75 minutes vigorous exercise for adults, Sciamanna explained.

The FAST-2 program included four exercises: push-ups, chair stands, two-arm rows and stair stepping. Participants performed each movement for 30 seconds followed by a 30-second rest. Participants received four elastic resistance bands and a stepper with an adjustable height. Written explanations and modifications were provided for the exercises, such as performing pushups with hands on a countertop or wall, or chair stands with hands on the knees.

As participants improved, they were encouraged to progress to higher levels of difficulty, like performing the original version of the exercise if they were doing a modified version or increasing step height on the stepper. To measure participants’ progress, the researchers assessed the participants’ ability and speed at standing up and ability to stand on one leg at the beginning, middle and end of the study.

The tests mimic the movements required in everyday activities, making them useful predictors of potential risks and future need for care, the researchers said.

The authors found that this exercise regimen, which included only 60 seconds of lower body resistance training, was enough to give significant improvements in functional performance: 4.2 more repetitions in a 30 second chair stand, 3.6 more seconds in one-legged stand time and a decrease of 2.3 seconds in sit-to-stand time. These changes point to related improvements in daily life fitness, such as standing up from a chair, climbing stairs and walking, Sciamanna explained.

“These indicators predict your future ability to go into a nursing home, your future likelihood of falling and of developing difficulty walking,” Sciamanna said. “They give you a sense of whether or not you're going to be able to be active in the future.”

One of the additional benefits of a shorter program like FAST-2, Sciamanna explained, is a higher chance that people will stick to the routine. Participants completed the exercise on 81% of days during the study period, demonstrating that the program can fit into days even with time constraints or other concerns that may keep people from continuing an exercise program, even though it could lead to improvements in everyday life.

The findings are a promising indication that resistance training regimens do not have to be long to make a big difference in strength, mobility and quality of life, Sciamanna explained.

“Exercise is the key to freedom,” he said. “Freedom is the ability to be able to do what you want to do, and I would say that if you can't do what you want to do, you're not free. I approach exercise by thinking of what I want to be able to do in 20 years, and then I train to do that.”

Pregnant women may reduce key health risk through less sitting, more light exercise

Women who engage in light physical activity and lessen their sedentary time may significantly reduce the risk of key health problems during pregnancy, according to a new University of Iowa-led study.

Researchers examined the daily behaviors of 470 pregnant women across all stages of pregnancy. Each participant wore a monitor that measured physical activity in 24-hour cycles and another monitor that recorded the time they spent asleep.

Based on observational data collected from the study’s participants, the researchers propose a “Goldilocks Day”-like guide for pregnant women that could reduce by nearly 30% the risk of developing hypertensive disorders of pregnancy (HDP), commonly occurring complications of pregnancy that include chronic hypertension, gestational hypertension, and preeclampsia.

Those recommendations are:

• Reduce sedentary time to fewer than eight hours each day.

• Engage in light physical activity for at least seven hours each day.

• Engage in approximately 22 minutes of moderate to vigorous physical activity, such as a brisk walk, each day.

• Get nearly nine hours of sleep each night.

Sedentary behavior is defined as being mostly inactive, such as sitting or lying down. Light physical activity can include myriad options, such as taking a casual walk, moving around the home, or simply standing. 

“We are identifying the optimal composition of movement behaviors across the day associated with the lowest risk of developing HDP and the most improved health outcomes,” says Kara Whitaker, associate professor in the Department of Health, Sport, and Human Physiology at Iowa and the study’s corresponding author. “This blueprint holds for each and every trimester of pregnancy.”

Study participants were enrolled at study sites in Iowa City, Iowa; Pittsburgh; and Morgantown, West Virginia. The women, 4 in 5 of whom were non-Hispanic white and nearly a quarter of whom were rural residents, wore the activity and sleep monitors for at least a week during each trimester of pregnancy.

The data showed a steep increase in HDP risk for pregnant women who were sedentary for more than 10 hours per day. Conversely, pregnant women who upped their light physical activity to at least four hours per day reduced their HDP risk to 15% from 30%.

“Just moving around more seems to have significant health benefits,” Whitaker says, “and I think it also may be a more feasible target for women who are pregnant who are not exercising regularly.”

The researchers were surprised to find out that participants who engaged in moderate to vigorous physical activity showed no appreciable benefit from longer durations, while sleep beyond a certain duration also yielded no major benefits.

“Through this study, we are providing evidence that reducing sedentary behavior and engaging in light physical activity are important, and maybe more important, when it comes to pregnancy and health,” Whitaker says.

Knowing which mix of behaviors has the greatest impact on women’s health in pregnancy is important, Whitaker notes, because clinical research has shown that women who develop HDP are more than twice as likely to develop heart disease later in life.

“We know that cardiovascular disease is the number one killer of women, and if we can intervene in pregnancy and prevent women from developing a hypertensive disorder of pregnancy, we are putting them on a better trajectory, away from cardiovascular disease and toward more optimal cardiovascular health,” she says.

The study, “Optimal 24-hour movement behaviour compositions across trimesters and risk of hypertensive disorders of pregnancy: the Pregnancy 24/7 cohort study,” was published online June 10 in the British Journal of Sports Medicine.

The findings complement a second study, published online May 27 in the Journal of the American Medical Association, that looked more in depth at the ratio and type of sedentary behavior and light physical activity for the best mix of behaviors to lessen HDP risk. Whitaker is a lead co-author on that study.

Co-authors in the British journal’s study are Alex Crisp, Jaemyung Kim, Karina Smith, Donna Santillan, Mark Santillan, and Bridget Zimmerman, from Iowa; Jacob Gallagher, from Iowa State University; Melissa Jones, from Oakland University in Michigan; Bethany Barone Gibbs, Katrina Wilhite, Alexis Thrower, and Iqra Sheikh, from West Virginia University; and Sabera Rahman, Janet Catov, Christopher Kline, and Maisa Feghali, from the University of Pittsburgh. 

The National Institutes of Health, the University of Iowa Institute for Clinical and Translational Science, the University of Pittsburgh Clinical and Translational Science Institute, and the West Virginia Clinical and Translational Science Institute funded the research.

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Journal

British Journal of Sports Medicine

DOI

10.1136/bjsports-2025-111091