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.”

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.

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.

“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. 

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.