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.

“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.

“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)

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.”

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.

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“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.

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. 

“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)

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.

Fox News Digital reached out to Vertex for additional comment.

“Make America Healthy Again” (MAHA) became a rallying cry during the final months of the 2024 presidential election, after Robert F. Kennedy Jr. endorsed President Donald Trump and joined his campaign.

A little over a week after Election Day 2024, Trump announced Kennedy as his pick to lead the Department of Health and Human Services (HHS). 

Under Kennedy’s leadership, the MAHA movement aims to improve nutrition in America, eliminate toxins, preserve natural habitats and fight the chronic disease epidemic, according to its website.

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Read on to learn more about some of the key players behind the MAHA movement.

Robert F. Kennedy Jr.

Robert F. Kennedy Jr. is a former presidential candidate, son of former Sen. Robert F. Kennedy and President Trump’s pick for HHS secretary. 

Robert F. Kennedy Jr. is a former presidential candidate and President Donald Trump’s pick for HHS secretary. (Jon Cherry/Getty Images)

Kennedy has said he aims to make America healthy again through strategies such as focusing on food and nutrition, targeting chronic diseases, changing FDA policies and raising awareness of alternative health treatments. 

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Jessica Reed Kraus 

Jessica Reed Kraus, author of the “House Inhabit” substack, spoke to Fox News Digital during RFK Jr.’s confirmation hearing. (Fox News Digital)

Jessica Reed Kraus is the author of “House Inhabit,” one of the top culture Substack blogs. The California-based influencer previously described herself as “super liberal,” but her politics shifted during the coronavirus pandemic. 

Kraus worked with both the Trump and RFK Jr. presidential campaigns, and she wrote glowingly about the MAHA Inaugural Ball in her Substack.

Marla Maples

Marla Maples, ex-wife of President Donald Trump and mother of Tiffany Trump, was among the supporters who appeared on Capitol Hill this past Wednesday during the confirmation hearing for HHS secretary. 

Marla Maples shared her excitement for the MAHA movement and her hopes for a healthier America with Fox News Digital at the RFK Jr. hearing on Jan. 29 on Capitol Hill.  (Fox News)

The Georgia native, also a co-founder of the Global Wellness Forum, shared her excitement for the MAHA movement and her hopes for a healthier America.

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“I have to support America’s health, our children’s health … We suffered [for] so long with what they’re putting in our food supply without having consent on what we’re getting medically,” she told Fox News Digital in an interview. 

Jillian Michaels

Jillian Michaels is a renowned fitness expert based in Miami, Florida. As a certified personal trainer and nutrition specialist, she takes a no-nonsense approach to health and wellness. 

In Sept. 2024, Michaels (shown above) appeared in a “Make America Healthy Again” ad with Brigham Buhler. (Donald Kravitz/Getty Images)

In Sept. 2024, Michaels appeared in a “Make America Healthy Again” ad with healthcare entrepreneur Brigham Buhler.

Alex Clark

Alex Clark is the host of the “Culture Apothecary” podcast. She speaks with guests who share their own healing remedies for those seeking alternative healthcare methods. 

A contributor to the nonprofit political organization Turning Point USA, the Arizona-based Clark has over 120,000 followers on X and nearly half a million Instagram followers.

Vani Hari (‘Food Babe’)

Known as the “Food Babe,” Vani Hari has been raising alarms about chemicals in food, water and the air for over a decade. 

Vani Hari is a food activist who attended the confirmation hearing for Robert F. Kennedy Jr., prospective secretary of Health and Human Services. (AP Photo/Ben Curtis)

Based in North Carolina, the mother of three is the author of several books and the “Food Babe” blog. 

As a food activist, Hari aims to influence major food giants to adopt healthier policies.

Caitlin Sinclair

Caitlin Sinclair, who is with Turning Point Action, spoke with Fox News Digital about her personal connection to the MAHA movement.

Caitlin Sinclair, pictured with RFK Jr., told Fox News Digital that the “MAHA movement is very personal to me.”  (Turning Point Action)

Sinclair experienced a “dark, seven-year odyssey” of wrongful diagnoses, she shared. 

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The MAHA movement is part of a “spiritual awakening” in the U.S. that is key to helping people achieve the American dream, she said.

Calley Means

Calley Means is a New York City-based entrepreneur, author and advocate for healthcare reform, focusing on the intersection of food, policy and chronic disease. 

Calley Means is an entrepreneur, author and advocate for healthcare reform, focusing on the intersection of food, policy and chronic disease.  (Fox News Digital)

Means co-founded TrueMed, a company in Washington, D.C., that helps Americans use health savings accounts (HSAs) and flexible spending accounts (FSAs) for preventative health measures like nutrition and fitness. 

He also co-wrote the book “Good Energy” with his sister, Casey Means, M.D. 

Casey Means, MD

Dr. Casey Means is a Stanford-trained physician and metabolic health expert based in Los Angeles.

Casey Means attended the confirmation hearing for Robert F. Kennedy Jr., whom President Trump has nominated to be secretary of HHS. (Fox News Digital)

Formerly a surgeon, she shifted her focus to preventive medicine, emphasizing the role of diet and lifestyle in combating chronic disease. 

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Means focuses on metabolic health, highlighting the connections between blood sugar, inflammation and long-term wellness. She was among the supporters who attended the confirmation hearing for RFK Jr. on Jan. 29.

Nicole Saphier, MD

Dr. Nicole Saphier wrote the book “Make America Healthy Again” in 2020, spearheading the MAHA movement. (Fox News)

Nicole Saphier, M.D., a board-certified radiologist with advanced fellowship training in breast imaging, is a Fox News medical contributor and bestselling author. 

The New York City-based doctor also wrote the book “Make America Healthy Again” in 2020, spearheading the MAHA movement. 

Liana Werner-Gray

An Australian who now calls Los Angeles home, Liana Werner-Gray said her life changed dramatically in 2009 at age 21, when she was told she had cancer in her lymphatic system.   

After a cancer diagnosis, Liana Werner-Gray embarked on a “massive detox” by carefully choosing what foods to consume.  (Johnny Nunez/WireImage)

Eschewing traditional medicine, Werner-Gray embarked on a “massive detox” and changed her diet. She is the author of “The Earth Diet” and several other books.

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The wellness advocate spoke with Fox News Digital about her personal health journey while attending RFK Jr.’s confirmation hearing.

Daphne Oz

Daphne Oz is an Emmy-winning TV host, author and wellness advocate known for her expertise in healthy living, nutrition and balanced lifestyle choices. She is based in Florida.

Daphne Oz has grown her career by focusing on healthy living and nutrition.  (Brad Barket/Getty Images)

As the daughter of Dr. Mehmet Oz, Daphne Oz has built a career emphasizing the importance of nourishing foods, mindful indulgence and wellness. She was recently spotted at the MAHA inaugural ball held in celebration of RFK Jr. on Jan. 20. 

A man who is 92 years old is not only still competing in his activity of choice — he’s teaching others the secrets of how to live a long, healthy and fulfilling life.

Ivan Pedley, a retired toolmaker, plays ping pong twice a week — and said he has no plans to stop doing so any time soon.

The grandfather of three took up the paddle sport when he was just 14 years old, news agency SWNS reported — and now, 78 years later, he’s still strongly involved in it.

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The retiree plays roughly 14 games a week at the Great Wryley Table Tennis Club in Staffordshire, West Midlands, England.

He often goes up against opponents who are much younger than he is, SWNS said.

And while he may have slowed down a bit over time, Pedley said he rarely gets knocked off the table and that success at the sport is all about “technique.”

He said that regular ping pong playing helps him stay fit and healthy — and that continuing to play it well into his senior years is the best thing he’s ever done.

“It’s the best thing I’ve ever done.”

Said Pedley, who lives in Walsall, West Midlands, “I enjoy every minute of it.”

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He added, “It’s the best thing I’ve ever done. I don’t know anyone older than 92 [who is still] playing.” 

Sprightly retiree Pedley plays about 14 games of ping pong each week.  (SWNS)

He said that while the others who play might be “faster” than he is, “it’s all in the technique.”

There are “a lot of people in their 60s” who play, he said, “but I play the younger people, too. I try to play everybody at the club.”

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He continued, “I’ll keep going for as long as I can, as long as my health stays. Sitting on your backside is no help to anyone.”

He said he first found his passion for ping pong while he was a teenager — and let it go for awhile when he was in his 20s.

Pedley (center, front) said he has no plans to retire from playing ping pong. He’s a grandfather of three and first took up the paddle sport as a teenager.  (SWNS)

But once he reached his 60s, he rediscovered his love of the sport following a chance game with a friend while on vacation, he said.

He then started playing regularly again while also continuing to stay involved in bowling, swimming and judo — in which he is a brown belt.

“I like to keep myself healthy … I keep going.”

Pedley said that he believes he’s gotten better at ping pong because of the standard of skill in those he’s playing against these days.

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He added jokingly, “I do let these [them] win sometimes, though, because I don’t want to dishearten them.”

Pedley goes to the club on Tuesdays and Fridays, he said — spending as long as three hours there each time.

Pedley said ping pong helps him stay fit and healthy — and that playing as a senior is one of the best things he’s ever done. (SWNS)

He said, “I don’t want to sit here and do nothing. I like to keep myself healthy … I keep going. It makes me get up and do it.”

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He added about being part of a club, “Once you’re committed, you have to try and turn up. I’d tell anyone to join a club to start with.”

“He’ll always put his heart into it.”

He said, “I’ve done amateur competitions. I’ve got certificates from what I’ve achieved at table tennis.”

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Club secretary Tony Reeds told SWNS about Pedley, “He’ll always put his heart into it.”

He said that Pedley will play against “anyone” who comes into the club to play ping pong.

Pedley is shown at left during a match. He said that while he may have slowed down over the years, the trick is “all in the technique.” (SWNS)

The 92-year-old often goes up against opponents who are much younger than himself. (SWNS)

“He’s part of the furniture now. He’s had some good games.”

Pedley tells people, “If you want to keep fit, this is the way to do it,” Reeds also noted.

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Older people are wise to stay active, eat well, remain connected to others and take care of themselves both physically and mentally in other ways as well, health and medical experts have long said.