FDA Approves New Non-Opioid Pain Pill, Journavx, for Acute Pain
Federal officials have approved a new pain medication designed to eliminate the risks of addiction and overdose associated with opioid painkillers like Vicodin and OxyContin.
The U.S. Food and Drug Administration (FDA) announced on Thursday that it has granted approval for Journavx, a non-opioid pain pill developed by Vertex Pharmaceuticals. The drug is intended for short-term pain management, particularly after surgeries or injuries.
A New Approach to Pain Relief
Journavx marks the first major pharmaceutical breakthrough in pain treatment in over 20 years, offering an alternative to both opioids and common over-the-counter pain relievers like ibuprofen and acetaminophen.
Unlike opioids, which relieve pain by binding to receptors in the brain, Journavx works by blocking proteins that trigger pain signals before they reach the brain. This unique mechanism eliminates the risk of addiction and overdose—two major concerns with traditional opioid medications.
However, studies show Journavx’s effectiveness is limited. In clinical trials involving more than 870 patients recovering from foot and abdominal surgeries, the drug provided more relief than a placebo, but it was not more effective than a common opioid-acetaminophen combination pill.
“It’s not a slam dunk on effectiveness,” said Michael Schuh, a pain medicine expert at the Mayo Clinic. “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 of promise.”
Cost and Side Effects
Journavx will have a list price of $15.50 per pill, making it significantly more expensive than generic opioid medications, which cost as little as $1 per pill.
Common side effects reported in clinical trials include nausea, constipation, itching, rash, and headaches.
“The side effect profile is not only different but lacks the substance abuse risks associated with opioids,” said Dr. Charles Argoff of Albany Medical Center, who consulted on the drug’s development.
Challenges and Uncertain Future
Vertex Pharmaceuticals began researching the drug in the early 2000s, at a time when opioid prescriptions were skyrocketing. While opioid prescriptions have declined in the last decade, the current overdose crisis is primarily driven by illicit FYL, rather than prescription painkillers.
Despite high hopes for Journavx, Vertex’s stock took a hit in December after disappointing trial results in patients with chronic nerve pain in the lower back and legs. The drug did not significantly outperform a placebo in that study, raising concerns about its broader potential.
Still, Vertex remains committed to further research, with plans to launch a new late-stage trial to improve the drug’s chances of approval for chronic pain treatment.
The Bigger Picture
Journavx’s approval represents a step forward in the search for safer pain treatments, but its high cost and modest effectiveness raise questions about how widely it will be used.
For now, opioids remain the most effective option for severe pain, though the risks of addiction continue to drive demand for alternatives.
Source: WTTW