• Posted January 31, 2025

FDA Approves First New Non-Opioid Pain Pill in Decades

The U.S. Food and Drug Administration (FDA) has approved Journavx, a new pain reliever without the risks of addiction or overdose linked to drugs like Vicodin and OxyContin.

The new pill, developed by Vertex Pharmaceuticals, is intended for short-term pain relief following surgery or injury, the Associated Press reported. 

While it provides a long-awaited alternative to opioids and over-the-counter painkillers like ibuprofen, research suggests its effectiveness is modest compared to standard opioid treatments.

Unlike opioids, which bind to brain receptors to reduce pain but often lead to dependence and addiction, Journavx works differently.

The medication blocks specific proteins that trigger pain signals before they reach the brain.

“In trying to develop medicines that don’t have the addictive risks of opioid medicines, a key factor is working to block pain signaling before it gets to the brain,” Dr. David Altshuler, Vertex’s executive vice president and chief scientific officer, previously told the Associated Press.

Studies of more than 870 patients who took Journavx after foot and abdominal surgery showed that the drug provided more relief than a placebo but was not more effective than a common opioid-acetaminophen combination pill.

“It’s not a slam dunk on effectiveness,” Michael Schuh of the Mayo Clinic, a pharmacist who was not involved in the research, told the Associated Press. “But it is a slam dunk in that it’s a very different pathway and mechanism of action. So, I think that shows a lot promise.”

One major concern is cost. Journavx will have a list price of $15.50 per pill, compared to generic opioids, which cost $1 or less.

Some reported side effects included nausea, constipation, itching, rash and headache, but no risk of addiction.

“The new medication has side effect profiles that are inherently, not only different, but don’t involve the risk of substance abuse and other key side effects associated with opioids,” Dr. Charles Argoff of the Albany Medical Center in New York, who consulted for Vertex on the drug’s development, told the Associated Press.

The approval marks the first major advancement in pain treatment in more than two decades. 

Vertex began developing the drug in the early 2000s, as opioid overdoses surged due to mass prescribing for chronic conditions like arthritis and back pain.

While opioid prescriptions have sharply declined in recent years, the current epidemic is mostly fueled by illicit fentanyl, rather than pharmaceutical opioids, the Associated Press reported.

Vertex has attracted much interest, but the drugmaker's stock took a hit in December after disappointing results in a study of chronic nerve pain.

Despite this, the company plans to continue with another late-stage trial in hopes of getting FDA approval for chronic pain treatment.

More information

The Cleveland Clinic has more on living with chronic pain.

SOURCE: The Associated Press, media report, Jan. 31, 2025