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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.Β 

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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 β€” which is a drug that inhibits sodium channels β€” works outside the brain on pain receptors," she noted.

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

Acute pain β€” sudden or urgent pain that results from injury, trauma or surgery β€” 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."

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.

"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.

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.

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.

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.

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

"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.Β 

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

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.

Alcohol linked to cancer risk in US surgeon general's new advisory

The U.S. surgeon general has released a new advisory warning of alcohol-related cancer risk.

Dr. Vivek Murthy issued the guidance on Friday following research that has linked alcohol to at least seven types of cancer.

In particular, the advisory notes that alcohol can increase the risk of throat, liver, esophageal, mouth, larynx (voice box), colon and rectal cancers.

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Alcohol consumption has been named as the "third leading preventable cause of cancer" in the country, the advisory noted, with tobacco and obesity taking the top two spots.

"Alcohol is a well-established, preventable cause of cancer responsible for about 100,000 cases of cancer and 20,000 cancer deaths annually in the United States β€” greater than the 13,500 alcohol-associated traffic crash fatalities per year in the U.S. β€” yet the majority of Americans are unaware of this risk," said Murthy in the advisory.Β 

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"This Advisory lays out steps we can all take to increase awareness of alcohol’s cancer risk and minimize harm."

The advisory breaks down four different ways in which cancer can increase cancer risk.

In one mechanism, the alcohol breaks down into a chemical called acetaldehyde, which damages DNA and increases cancer risk.

Alcohol also induces "oxidative stress," the advisory warns, which damages protein, DNA and cells, and also causes inflammation.

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In a third mechanism, alcohol changes hormone levels, namely estrogen, which can increase the risk of breast cancer. More than 16% of all breast cancer cases have been linked to alcohol, the advisory states.

Finally, cancer creates conditions in which alcohol is more easily absorbed into the body.

Individual risk for alcohol-related cancers will also depend on "a complex interaction of biological, environmental, social and economic factors," the same source stated.

In the new advisory, Murthy calls for a warning label to be placed on alcoholic beverages stating that they may increase cancer risk.

The advisory also calls for a "reassessment of the guideline limits" for alcohol consumption and encourages people to be cognizant of the risk when deciding how much to consume.

The surgeon general also calls for doctors, health professionals and community groups to emphasize the link between alcohol and cancer to help raise awareness of the risk.

Dr. Marc Siegel, clinical professor of medicine at NYU Langone Health and Fox News senior medical analyst, applauded Murthy's advisory.

"Too many Americans are living with an outdated assumption that some amount of alcohol is not only harmless, but also good for you," he told Fox News Digital. "Increasing evidence shows that isn't true."

Though wine and other alcoholic beverages may relieve stress and dilate arteries in the short term, the doctor warned that alcohol is a "proven toxin" with direct links to liver, heart and brain disease.Β 

"Even though traditional advice has been up to one drink a day for women and two drinks per day for men, in fact, no amount of alcohol is healthy," Siegel said.

Multiple studies have shown that 25% of people increased their alcohol use during the pandemic, according to Siegel.

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"This was in part because of stress and also because of social isolation β€” and the numbers have persisted since the pandemic ended," he said.

"The timing of this advisory is right on the mark."

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