FDA approves first opioid-free painkiller in over two decades

RICHMOND, Va. (WRIC) -- The U.S. Food and Drug Administration (FDA) has approved Journavx, the first opioid-free prescription drug for moderate to severe acute pain in more than 20 years.

The approval comes amid ongoing efforts to combat the opioid crisis, which has claimed thousands of lives across the United States.

Until now, patients experiencing acute pain had limited options--either relying on over-the-counter medications, which may not be strong enough, or turning to opioids, which carry a high risk of addiction.

Journavx offers a new alternative that health experts say could provide effective pain relief without the same risk of dependency.

According to the Centers for Disease Control and Prevention (CDC), opioid-related deaths have surged over the past two decades, with fatalities in 2022 reaching nearly ten times the number recorded in 1999. While the epidemic initially stemmed from prescription opioid abuse, it later shifted toward heroin overdoses and, more recently, the widespread use of synthetic opioids like fentanyl.

Dr. Hamid Akbarali, a pharmacology and toxicology professor at Virginia Commonwealth University (VCU), explains "One of the side effects of opioids is not only that you become addicted and might overdose, but the reason you overdose is because you become tolerant to it," Akbarali explained "As you take more and more, you become more tolerant so you take more and more until you get to the point you overdose."

Unlike opioids, Journavx works by blocking pain signals before they reach the brain. It targets sodium ion channels in the nerves—an approach that scientists have long sought in pain management research.

"That's the beauty of this drug--it is, in fact, a drug that's very specific compared to some of the other ones we've had," Akbarali added.

The FDA's approval is based on three clinical trials that found Journavx to be as effective as opioids in reducing pain, but with a faster onset and fewer side effects. Akbarali believes the drug’s success could pave the way for further advancements in pain management, particularly for chronic pain sufferers seeking non-addictive alternatives.

"Whether we get better drugs that come down the pipeline, both this company and others will have more potent, more efficacious drugs which may be more effective," he said.

Despite its promising potential, questions remain about the long-term effects of Journavx.

"Those are the questions we need to answer: What happens with long-term use of this drug?," Akbarali said. "Does it relieve pain to the same extent, or does it actually go away?"

While Journavx is not yet available in pharmacies, its approval marks a significant step forward in the fight against opioid dependency.

Early trials suggest the drug is effective across different age groups and types of pain, giving hope to millions of patients seeking safer pain relief options.