Health
New nasal spray to reverse fentanyl and other opioid overdoses gets FDA approval in U.S.


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WASHINGTON (AP) — U.S. health regulators on Monday approved a new easy-to-use version of a medication to reverse overdoses caused by fentanyl and other opioids driving the nation’s drug crisis.
Opvee is similar to naloxone, the life-saving drug that has been used for decades to quickly counter overdoses of heroin, fentanyl and prescription painkillers. Both work by blocking the effects of opioids in the brain, which can restore normal breathing and blood pressure in people who have recently overdosed.
The Food and Drug Administration endorsed Opvee, a nasal spray update of the drug nalmefene, which was first approved as an injection in the mid-1990s but later removed from the market due to low sales. Naloxone comes as both a nasal spray and injection.
It’s not immediately clear how the new drug will be used differently compared to naloxone, and some experts see potential downsides to its longer-acting effect. The drug will be available via prescription and is approved for patients 12 and older.
In studies funded by the federal government, Opvee achieved similar recovery results to Narcan, the leading brand of naloxone nasal spray.
Opvee was developed by Opiant Pharmaceuticals, which was recently acquired by rival Indivior, maker of several medications for opioid addiction. Indivior expects to launch Opvee in October at the earliest.
As the opioid epidemic has shifted to fentanyl and other synthetic opioids, researchers in the pharmaceutical industry and the U.S. government saw a new role for the drug.
Because fentanyl stays in the body longer than heroin and other opioids, some people may require multiple doses of naloxone over several hours to fully reverse an overdose.
Scientists at the National Institutes of Health worked with pharmaceutical researchers on a nasal spray version of nalmefene that would quickly resuscitate users, while also protecting them from relapse. Testing and development was funded by more than $18 million in grants from the U.S. government’s Biomedical Advanced Research and Development Authority and the NIH, which also helped design the studies.
“The whole aim of this was to have a medication that would last longer but also reach into the brain very rapidly,” said Dr. Nora Volkow, director of the National Institute on Drug Abuse.
Still, some experts see potential downsides.
A side effect of all opioid reversal drugs is that they create intense withdrawal symptoms including nausea, diarrhea, muscle cramps and anxiety. With naloxone, those symptoms might last 30 to 40 minutes.
Dr. Lewis Nelson of Rutgers University says those problems can last six hours or more with nalmefene, requiring extra treatment and management by health professionals.
“The risk of long-lasting withdrawal is very real and we try to avoid it,” said Nelson, an emergency medicine physician and former adviser to the FDA on opioids.
Nelson said it’s easy enough to give a second or third dose of naloxone if it wears off.
“We’re not suffering from a naloxone shortage where we need to use an alternative,” he said. “We have plenty of it and it works perfectly well.”
The FDA approval comes as drug overdose deaths inched up slightly last year after two big leaps during the pandemic. More than 109,000 fatal overdoses were recorded in 2022, according to the latest figures from the Centers for Disease Control and Prevention.
More than two-thirds of those deaths were linked to fentanyl and other synthetic opioids, which have largely replaced heroin and prescription opioids.
Naloxone has long been at the center of government efforts to fight the overdose crisis at the federal and local levels. Police, firefighters and other first responders routinely carry the drug. And officials in all 50 states have given orders to pharmacists to sell or dispense the drug without a prescription to anyone who wants it.
In the latest federal push, the FDA recently approved Narcan to be sold over the counter. The change will allow the new version of the drug to be stocked in grocery stores, vending machines and other retail locations. The nasal spray — which includes updated instructions for regular users — is expected to launch this summer. Emergent Biosolutions hasn’t yet announced a price for the over-the-counter version.
Indivior said it is still considering what to charge for its drug. It will compete in the same market as naloxone, where most buyers are local governments and community groups that distribute to first responders and those at risk of overdose. Indivior has told investors that Opvee could eventually generate annual sales between $150 million to $250 million.
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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.





Health
Tests from a pair of bats confirm Hamilton’s first two rabies cases for 2023
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Hamilton public health (HPH) confirmed on Thursday a pair of bats recently tested positive for rabies, the first cases since last summer.
The city says, so far, there have been no reported interactions with humans since a resident was bit early last year.
Health officials continue to advise Hamiltonians the city is still in a rabies outbreak, which started in 2016 primarily due to the discovery of at least 200 positive cases that year including 123 raccoons and 73 skunks.
Most cases over the last eight years have involved raccoons, accounting for 215 discoveries in all.
The overall risk for human infections from bats is low with only 13 confirmations in tests since 2016.
Despite going years without a positive raccoon rabies case, HPH supervisor Jane Murrell says they haven’t shaken off outbreak status due to incidents in neighbouring municipalities.
“The problem is Niagara region is still having some positives and we are within 50 kilometers,” Murrell explained.
Rabies is transmitted through the saliva of an infected animal — usually through a bite, but can also enter the body upon contact, through scratches, open wounds, or mucous membranes of the mouth, nose and eyes.
Murrell says the easiest way to eliminate the risk of contracting rabies is to avoid contact with animals that carry it, like the aforementioned bats, raccoons and skunks.
Hamilton included in Ontario’s ‘estimated risk areas’ for Lyme disease
Hamilton continues to be considered a risk area for black-legged ticks and has the potential for residents to contract Lyme disease.
Public Health Ontario has once again included the city on its latest map demonstrating the estimated risk areas for the affliction.
Murrell says despite the designation, the true risk of infection to residents is very low.
Public Health Ontario
More on Health
The Ontario Lyme Disease Map: Estimated Risk Areas is updated annually. It provides information to assist public health professionals and clinicians in their management of Lyme disease.
“There is potential for some of those ticks to carry the bacteria that causes Lyme disease but not all black-legged ticks carry that bacteria,” Murrell said.
“So the majority of our ticks in the city are still brown-legged dog ticks, which don’t carry Lyme.”
Hamilton hit a ten-year high in 2021 for Lyme disease cases acquired locally with 27 reported to HPH.
It’s a bump of more than 20 cases compared to the previous year (2020) when HPH had just six cases in the city.
Between 2013 and 2022, the city has been averaging just over two cases per year.
Public health is suggesting caution when removing a tick suggesting tweezers and grasping the bug as close to the skin as possible and pulling it straight out, gently but firmly.
Squeezing a tick should be avoided as it can cause secretions that can lead to Lyme disease to escape into a person’s body.
Lyme disease is caused by a bacterium called Borrelia burgdorferi, which is spread through the bite of infected black-legged ticks, according to Public Health Canada.
Typically, infected black-legged ticks need to be attached for at least 24 to 36 hours in order to transmit the bacteria that causes Lyme disease.
Symptoms can take anywhere from a few days to four weeks to appear. They include fever, headaches, tiredness and a skin rash at the bite location.
If untreated, the more severe scenarios include joint pain, severe headaches with neck stiffness or heart palpitations.





Health
Flavanols are linked to better memory and heart health – here’s what foods you can eat to get these benefits – Yahoo Canada Sports
There are plenty of good reasons to make sure you’re eating enough fruit and vegetables each day. Not only do fruit and vegetables contain many of the important vitamins and minerals our body needs to function at its best, they also keep our gut healthy and may even help maintain a healthy weight.
But some plant foods may be more beneficial for health than others, thanks to a group of compounds called flavanols.
For instance, a recent study I helped conduct showed that people who eat a diet high in flavanol-rich foods may have better memory compared to those who have a low intake. A previous study also found that people with a low intake of flavanols were at higher risk of heart disease. Overall, there’s convincing evidence that consuming enough flavanols has health benefits.
But while research shows that flavanols have many health benefits, it’s important for consumers to know that not all flavanol-rich foods contain the same amount of flavanols – meaning some may be more beneficial to health than others.
Plant compounds
Flavanols are a group of compounds that are found in many plants – including apples, berries, plums and even beverages such as tea.
There are two main groups of flavanols, with many different subgroups. Each plant will contain different combinations of flavanols, as well. These compounds each have different structures and different effects on the body. That means that not all flavanols are created equal.
For example, a portion of blueberries and a cup of tea may contain the same amount of total flavanols – but they are made up of completely different types of flavanols, which may have completely different health effects.
So in order to investigate the health effects of flavanols, it’s therefore important to use a source which includes a wide range of different types. This is why flavanols extracted from cocoa are an ideal model, as they contain the two main types of flavanols. It also allows researchers to calculate which other foods are likely to have benefits based on how similar the compounds they contain are to cocoa flavanols.
Since foods such as cocoa, berries and tea contain a combination of many types of flavanols, it’s currently not clear which individual compounds generate health benefits. But some research has linked the specific flavanol epicatechin with better vascular function. Cocoa and tea both contain epicatechin.
Many different types
Another thing to know is that even if a food contains flavanols, it may contain lower amounts compared to others.
To better understand how flavanol intake affects health, a few years ago we developed a test that uses urine to measure flavanol intake. The test is based on the way the human body processes flavanols and tells us whether someone has eaten large amounts, small amounts or no flavanols at all.
Using this test, we were able to show that people with high flavanol intake had lower blood pressure and better memory than those with lower intake.
When we developed the urine test, we also investigated how it is affected by different types of flavanols and foods. This allowed us to estimate what amount of different flavanol-rich foods a person needs to consume to achieve approximately 500mg of flavanols per day – similar to the amount used in studies, which has been shown to have clinical benefit.
According to our research, only two-and-a-half cups of green tea are needed daily to get the recommended 500mg of flavanols. Just under a cup of millet (sorghum grain) can also provide you with the recommended daily amount.
But if you were to try and get your flavanols from one type of fruit and vegetable, our research shows you’d need to consume large amounts of each to achieve the recommended amount. For example, you’d need to consume nearly 15 cups of raspberries alone to get 500mg of flavanols.
As such, the best way to get enough flavanols daily is by consuming a combination of different fruits and vegetables. For example two apples, a portion of pecan nuts and a large portion of strawberries can achieve the 500mg target – or a salad made with millet and fava beans.
It’s also important to note that while the flavanols used in many studies were extracted from cocoa, unfortunately chocolate (even dark chocolate) is a very poor source of flavanols – despite what some headlines might claim. This is because these flavanols are lost during processing.
Although there’s still much we don’t know about flavanols – such as why they have the effect they do on so many aspects of our health – it’s clear from the research we do have that they are very likely beneficial to both memory and heart health.
This article is republished from The Conversation under a Creative Commons license. Read the original article.



Gunter Kuhnle has received research funding from Mars, Inc., a company engaged in flavanol research and flavanol-related commercial activities.
Health
‘Social deprivation’ speeds up aging, and death: McMaster study
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We are dying every day, wrote Seneca, a stoic philosopher in ancient Rome.
And if you struggle living alone or have weak familial bonds, you risk speeding up death by as much as one year, according to findings published by McMaster University on Monday.
The new study shows that biological clocks tick faster for those dwelling in an environment of social deprivation (a dearth of family or community network resources) or material poverty, such as lacking access to quality housing, healthy food and recreation.
McMaster’s Divya Joshi, the study’s first author, said the findings indicate that living in a “deprived urban neighbourhood” marked by either form of deprivation is associated with “premature biological aging.”
Joshi is a research associate in the university’s Department of Health Research Methods, Evidence and Impact.
“If your (biological) systems are aging faster than your chronological age, then you will have more poor health outcomes, or quicker health outcomes, than someone who is aging slower biologically,” she told The Spectator.
The study analyzed DNA from the blood samples of 1,445 participants across Canada, who are part of the Canadian Longitudinal Study on Aging that is following 50,000 people between age 45 to 85.
“Epigenetic clocks” studied in the samples — also called “DNA methylation-based estimators” — indicated aging at the cellular level, she said.
“To be able to see that living in a socially or materially deprived neighbourhood impacts your healthy aging; that it increases your risk of epigenetic age acceleration by almost a year, beyond your individual health status — I think that is just remarkable,” she said.
When your biological age outpaces your calendar age, she said you have a greater risk of cardiovascular disease, respiratory conditions and neurological disorders that present a “greater risk of premature mortality.”
The findings fit their research hypothesis, she said, but what didn’t fit was the assumption that depression in the test subjects would further “amplify” the rapid aging effect.
In fact, while depression symptoms also contributed to epigenetic aging, environmental factors impacted aging acceleration regardless of depression symptoms.
The findings were published June 5 in “The Journals of Gerontology, Series A: Biological Sciences and Medical Sciences.”
McMaster professor Parminder Raina led the research team, which included investigators from the Netherlands, Norway and Switzerland, according to a news release.
While the presentation of the findings focused on the connection to disadvantaged neighbourhoods, Joshi agreed that an individual will age more rapidly when deprived of familial or social bonds, regardless of where they live.
“That is true, there is evidence that those people who have poor social networks or broken family units have a greater risk of higher epigenetic age acceleration … It is aging you, and that is so relevant coming out of the pandemic, and the isolation many people experienced, especially the toll it had on our older populations.”





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