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FDA approves opioid-free pain medication with 'no sign of addiction'

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FDA approves opioid-free pain medication with 'no sign of addiction'

A new opioid-free pain medication was approved by the U.S. Food and Drug Administration (FDA) on Thursday, marking a non-addictive alternative for patients.

Journavx (suzetrigine), made by Vertex, is the “first and only approved non-opioid oral pain signal inhibitor,” according to a press release from the Massachusetts-based company.

The new drug is intended for treatment of moderate to severe acute pain in adults. 

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Importance of a non-opioid alternative

Patients with acute pain after surgery or due to a broken bone or an injury are often prescribed opioid medications, according to Julie Pilitsis, MD, PhD, a neurosurgeon at Banner – University Medicine and chair of the Department of Neurosurgery at the University of Arizona College of Medicine in Tucson.

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A new opioid-free pain medication was approved by the FDA on Thursday, marking a non-addictive alternative for patients. (iStock)

“This is the first time many patients receive opioids, and a subset of patients are known to go on to become dependent or addicted to the medications,” she told Fox News Digital.

“Patients with pain have had very few options to treat their pain with medications that don’t have addictive properties or side effects they can’t tolerate.”

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The main reason traditional pain relievers have addictive properties or intolerable side effects is that they work by modifying receptors in the brain, Pilitsis noted.

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“This medication — which is a drug that inhibits sodium channels — works outside the brain on pain receptors,” she noted.

“To have a non-opioid option to prescribe in these cases is exciting — and this is the first time in nearly two decades that we have something new to offer patients for acute pain.”

‘Major unmet need’

Acute pain — sudden or urgent pain that results from injury, trauma or surgery — affects more than 80 million Americans annually and is the most common reason for emergency department visits, according to statistics.

Around half of these will be prescribed an opioid, and 10% of those will have “prolonged opioid use.”

Acute pain — sudden or urgent pain that results from injury, trauma or surgery — affects more than 80 million Americans annually and is the most common reason for emergency department visits. (iStock)

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In 2023, more than five million Americans 12 and older reported a “prescription use disorder” within the past year, according to the Centers for Disease Control and Prevention (CDC).

Approximately 294,000 people died from prescription opioid overdoses between 1999 and 2022, the above source stated.

By managing acute pain effectively, suzetrigine may help prevent it from developing into chronic pain without the danger of dependency, meeting a “major unmet need,” noted Jianguo Cheng, MD, PhD, a pain management specialist at Cleveland Clinic.

“This is the first time in nearly two decades that we have something new to offer patients for acute pain.”

“Many current therapies rely on opioids, contributing to dependency and misuse,” he told Fox News Digital. “Suzetrigine’s non-opioid mechanism eliminates risks of misuse, addiction and respiratory depression, making it a safer alternative for acute pain management.”

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In addition to acute pain, suzetrigine may also be a solution for neuropathic (nerve) pain, depending on the results of further studies, the doctor added.

In addition to acute pain, suzetrigine may also be a solution for neuropathic (nerve) pain, depending on the results of further studies, a doctor noted. (iStock)

Dr. Marc Siegel, clinical professor of medicine at NYU Langone Health and Fox News senior medical analyst, also applauded the approval of suzetrigine.

      

“It has no sign of addiction, which makes it a hugely important new tool as we fight the opioid epidemic,” he told Fox News Digital.

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In clinical trials, the non-opioid medication received high patient satisfaction ratings, with 83% reporting “good” to “excellent” pain relief in real-world applications, Cheng noted.

“This drug is a big step forward and has been well-studied.”

Siegel noted that the drug has shown to decrease pain by about half, which he described as “excellent.”

“This drug is a big step forward and has been well-studied,” he added.

Access and side effects

Suzetrigine has become available for patients with acute pain, noted Pilitsis. 

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“It will be important to find physicians who are comfortable prescribing pain medications and to check with your insurance company to ensure that it is covered,” she advised.

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The medication is expected to fall under the Non-Opioids Prevent Addiction in the Nation (NOPAIN) Act, effective January 2025, which provides Medicare coverage for FDA-approved non-opioid pain therapies, according to Cheng. 

“This policy aims to improve access and affordability, ensuring suzetrigine’s inclusion in outpatient and surgical settings while reducing reliance on opioids,” he said. 

In 2023, more than five million Americans 12 and older reported a “prescription use disorder” within the past year, per the CDC. (iStock)

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The most common side effects of Journavx, according to the company’s website, include itching, muscle spasms, rash, and increased levels of an enzyme called creatine phosphokinase in the blood, among others.

The drug may also cause temporary fertility challenges.

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Certain medications can increase the risk of side effects and affect the drug’s effectiveness, the company cautioned, as can food or drink containing grapefruit.

Patients should see their doctor if any side effects become bothersome or do not go away.

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Fox News Digital reached out to Vertex for additional comment.

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Goodbye, Late-Night Cravings! How To Curb Hunger and Make Weight Loss Easier

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Goodbye, Late-Night Cravings! How To Curb Hunger and Make Weight Loss Easier


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Lurking dementia risk exposed by breakthrough test 25 years before symptoms

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Lurking dementia risk exposed by breakthrough test 25 years before symptoms

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A new blood test could determine a woman’s dementia risk as early as 25 years before symptoms emerge.

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That’s according to new research from the University of California San Diego, which found that a specific biomarker protein associated with early pathological processes of Alzheimer’s disease was “strongly linked” to future dementia risk.

The researchers analyzed blood samples from 2,766 participants in the Women’s Health Initiative Memory Study in the late 1990s, according to the study’s press release. 

KEY FITNESS MEASURE IS STRONG PREDICTOR OF LONGEVITY AFTER CERTAIN AGE, STUDY FINDS

The women ranged from 65 to 79 years of age and showed no signs of cognitive decline at the start of the study.

After tracking the participants for up to 25 years, the researchers concluded that the biomarker phosphorylated tau 217 (p-tau217) was “strongly associated” with future mild cognitive impairment and dementia. 

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A new blood test could determine a woman’s dementia risk as early as 25 years before symptoms emerge. (iStock)

Women who had higher levels of p-tau217 at the beginning of the study were “much more likely” to develop the disease. The findings were published today in JAMA Network Open.

“The key takeaway is that our study suggests it may be possible to detect risk of dementia two decades in advance using a simple blood test in older women,” first author Aladdin H. Shadyab, a UC San Diego associate professor of public health and medicine, told Fox News Digital. 

“These biomarkers may help us identify who is at greatest risk and develop strategies to delay or prevent dementia.”

“Our findings show that the blood biomarker p-tau217 could help identify individuals at higher risk for dementia long before symptoms begin,” he added.

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This long lead time could open the door to earlier prevention strategies and more targeted monitoring, rather than waiting until memory problems are already affecting daily life, according to Shadyab.

A specific biomarker protein associated with early pathological processes of Alzheimer’s disease was “strongly linked” to future dementia risk. (iStock)

“As the research advances, these biomarkers may help us identify who is at greatest risk and develop strategies to delay or prevent dementia,” he said.

This risk relationship wasn’t the same across the board, however. Women over 70 with higher p-tau217 levels had “poorer cognitive outcomes” compared to those under 70, as did those with the APOE ε4 gene, which is a known risk factor for Alzheimer’s disease.

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The study also found that p-tau217 was a stronger predictor of dementia in women who were randomly assigned to receive estrogen and progestin hormone therapy compared to those who received a placebo.

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“Blood-based biomarkers like p-tau217 are especially promising because they are far less invasive and potentially more accessible than brain imaging or spinal fluid tests,” said senior author Linda K. McEvoy, senior investigator at Kaiser Permanente Washington Health Research Institute and professor emeritus at the Herbert Wertheim School of Public Health, in the release. 

“Blood-based biomarkers like p-tau217 are especially promising because they are far less invasive and potentially more accessible than brain imaging or spinal fluid tests,” a researcher said. (iStock)

“This is important for accelerating research into the factors that affect the risk of dementia and for evaluating strategies that may reduce risk.”

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Blood tests for Alzheimer’s disease are still being studied and are not recommended for routine screening in people without symptoms, Shadyab noted. 

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More research is needed before this approach can be considered for clinical use prior to cognitive symptoms. 

Future studies should investigate how other factors — like genetics, hormone therapy and age-related medical conditions — might interact with plasma p-tau217, the researchers added.

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“The study examined only older women, so the findings may not necessarily apply to men or younger populations,” Shadyab noted. “We also examined overall dementia outcomes rather than specific subtypes such as Alzheimer’s disease.”

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Key fitness measure is strong predictor of longevity after certain age, study finds

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Key fitness measure is strong predictor of longevity after certain age, study finds

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For women over 60, muscle strength plays a critical role in longevity, a new study confirms.

Researchers at the University at Buffalo, New York, followed more than 5,000 women between the ages of 63 and 99, finding that those with greater muscle strength had a significantly lower risk of death over an eight-year period.

The findings were published in JAMA Network Open.

EXERCISE AFFECTS THE HEART IN A HIDDEN, POWERFUL WAY BY REWIRING NERVES, STUDY FINDS

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Muscle function was measured using grip strength and how quickly participants could complete five unassisted sit-to-stand chair raises. 

These are two tests commonly used in clinical settings to evaluate muscle function in older adults, the researchers noted.

A recent study shows that stronger muscle strength in women over 60 is linked to a lower risk of death over eight years. (iStock)

“In a community cohort of ambulatory older women, muscular strength was associated with significantly lower mortality rates, even when we accounted for usual physical activity and sedentary time measured using a wearable monitor, gait speed and blood C-reactive protein levels,” study lead author Michael LaMonte, research professor of epidemiology and environmental health at the University at Buffalo, told Fox News Digital.

“Movement is the key — just move more and sit less.”

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Many earlier studies did not include those objective measurements, making it difficult to determine whether muscle strength itself was linked to longevity, according to LaMonte. “Our study was able to better isolate the association between strength and death in later life,” he added.

Even for women who don’t get the recommended amount of aerobic physical activity, which is at least 150 minutes per week, muscle strength remained important for longevity, the researchers found.

Women with greater muscle strength were more likely to live longer, even if they did not meet the recommended amount of aerobic exercise. (iStock)

“The findings of lower mortality in those who had higher strength but were not meeting current national guidelines on aerobic activity were somewhat intriguing,” LaMonte said.

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Federal guidelines recommend strengthening activities one to two days per week, targeting major muscle groups.

Resistance training does not have to require a gym membership, LaMonte noted. These exercises can be performed using free weights, resistance bands, bodyweight movements or even household items, such as soup cans.

Experts recommend working major muscle groups one or two days a week using weights, bands or bodyweight exercises. (iStock)

“Movement is the key — just move more and sit less,” he said. “When we can no longer get out of the chair and move around, we are in trouble.”

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LaMonte acknowledged several limitations of the study. The researchers assessed muscle strength in older age but did not explore how earlier levels in adulthood might influence long-term health outcomes.

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“We were not able to understand how strength and mortality relate in younger ages,” he said, noting that future research should explore whether building strength earlier could have an even greater impact on longevity.

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