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

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

Journavx (suzetrigine), made by Vertex, is the "first and lone approved non-opioid oral symptom awesome inhibitor," according to a property merchandise from the Massachusetts-based company.

The caller cause is intended for attraction of mean to terrible acute symptom successful adults. 

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Importance of a non-opioid alternative

Patients with acute symptom aft country oregon owed to a breached bony oregon an wounded are often prescribed opioid medications, according to Julie Pilitsis, MD, PhD, a neurosurgeon astatine Banner – University Medicine and seat of the Department of Neurosurgery astatine the University of Arizona College of Medicine successful Tucson.

A caller opioid-free symptom medicine was approved by the FDA connected Thursday, marking a non-addictive alternate for patients. (iStock)

"This is the archetypal clip galore patients person opioids, and a subset of patients are known to spell connected to go dependent oregon addicted to the medications," she told Fox News Digital.

"Patients with symptom person had precise fewer options to dainty their symptom with medications that don’t person addictive properties oregon broadside effects they can’t tolerate."

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The main crushed accepted symptom relievers person addictive properties oregon intolerable broadside effects is that they enactment by modifying receptors successful the brain, Pilitsis noted.

"This medicine — which is simply a cause that inhibits sodium channels — works extracurricular the encephalon connected symptom receptors," she noted.

"To person a non-opioid enactment to prescribe successful these cases is breathtaking — and this is the archetypal clip successful astir 2 decades that we person thing caller to connection patients for acute pain."

‘Major unmet need’

Acute symptom — abrupt oregon urgent symptom that results from injury, trauma oregon country — affects much than 80 cardinal Americans annually and is the astir communal crushed for emergency department visits, according to statistics.

Around fractional of these volition beryllium prescribed an opioid, and 10% of those volition person "prolonged opioid use."

Acute symptom — abrupt oregon urgent symptom that results from injury, trauma oregon country — affects much than 80 cardinal Americans annually and is the astir communal crushed for exigency section visits. (iStock)

In 2023, much than 5 cardinal Americans 12 and older reported a "prescription usage disorder" wrong the past year, according to the Centers for Disease Control and Prevention (CDC).

Approximately 294,000 radical died from prescription opioid overdoses betwixt 1999 and 2022, the supra root stated.

By managing acute symptom effectively, suzetrigine whitethorn assistance forestall it from processing into chronic symptom without the information of dependency, gathering a "major unmet need," noted Jianguo Cheng, MD, PhD, a symptom absorption specializer astatine Cleveland Clinic.

"This is the archetypal clip successful astir 2 decades that we person thing caller to connection patients for acute pain."

"Many existent therapies trust connected opioids, contributing to dependency and misuse," helium told Fox News Digital. "Suzetrigine’s non-opioid mechanics eliminates risks of misuse, addiction and respiratory depression, making it a safer alternate for acute symptom management."

In summation to acute pain, suzetrigine whitethorn besides beryllium a solution for neuropathic (nerve) pain, depending connected the results of further studies, the doc added.

In summation to acute pain, suzetrigine whitethorn besides beryllium a solution for neuropathic (nerve) pain, depending connected the results of further studies, a doc noted. (iStock)

Dr. Marc Siegel, objective prof of medicine astatine NYU Langone Health and Fox News elder aesculapian analyst, besides applauded the support of suzetrigine.

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"It has no motion of addiction, which makes it a hugely important caller instrumentality arsenic we combat the opioid epidemic," helium told Fox News Digital.

In objective trials, the non-opioid medicine received precocious diligent restitution ratings, with 83% reporting "good" to "excellent" symptom alleviation successful real-world applications, Cheng noted.

"This cause is simply a large measurement guardant and has been well-studied."

Siegel noted that the cause has shown to alteration symptom by astir half, which helium described arsenic "excellent."

"This cause is simply a large measurement guardant and has been well-studied," helium added.

Access and broadside effects

Suzetrigine has go disposable for patients with acute pain, noted Pilitsis. 

"It volition beryllium important to find physicians who are comfy prescribing symptom medications and to cheque with your security institution to guarantee that it is covered," she advised.

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The medicine is expected to autumn nether the Non-Opioids Prevent Addiction successful the Nation (NOPAIN) Act, effectual January 2025, which provides Medicare sum for FDA-approved non-opioid symptom therapies, according to Cheng. 

"This argumentation aims to amended entree and affordability, ensuring suzetrigine’s inclusion successful outpatient and surgical settings portion reducing reliance connected opioids," helium said. 

In 2023, much than 5 cardinal Americans 12 and older reported a "prescription usage disorder" wrong the past year, per the CDC. (iStock)

The astir communal broadside effects of Journavx, according to the company’s website, see itching, musculus spasms, rash, and accrued levels of an enzyme called creatine phosphokinase successful the blood, among others.

The cause whitethorn besides origin impermanent fertility challenges.

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Certain medications tin summation the hazard of broadside effects and impact the drug’s effectiveness, the institution cautioned, arsenic tin nutrient oregon portion containing grapefruit.

Patients should spot their doc if immoderate broadside effects go bothersome oregon bash not spell away.

Fox News Digital reached retired to Vertex for further comment.