FDA Approves New Non-Opioid Pain Pill, But Questions Remain
A Breakthrough in Pain Treatment
Federal regulators have approved a first-of-its-kind pain medication designed to reduce the risks of addiction and overdose associated with opioids like Vicodin and OxyContin.
The U.S. Food and Drug Administration (FDA) announced Thursday that it has given the green light to Journavx, a pain pill developed by Vertex Pharmaceuticals for short-term pain relief, such as that experienced after surgery or injury.
A Long-Awaited Alternative to Opioids
Journavx marks the first major innovation in pharmaceutical pain treatment in over 20 years, offering a potential alternative to opioids and widely used over-the-counter drugs like ibuprofen and acetaminophen. However, its effectiveness remains modest compared to existing treatments.
Clinical trials involving over 870 patients with acute pain from foot and abdominal surgeries showed that Journavx provided more relief than a placebo but did not outperform a commonly prescribed opioid-acetaminophen combination.
“It’s not a slam dunk on effectiveness,” said Michael Schuh, a pharmacist and pain medicine expert at the Mayo Clinic, who was not involved in the research. “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.”
A Pricey Alternative
Journavx comes with a steep price tag—$15.50 per pill, significantly more expensive than generic opioids, which can cost as little as $1 per dose.
Vertex began developing the drug in the early 2000s, when opioid addiction rates surged due to widespread prescribing of painkillers for conditions like arthritis and back pain. While opioid prescriptions have sharply declined in the past decade, the current wave of the crisis is largely driven by illicit fentanyl rather than pharmaceutical opioids.
How Journavx Works
Unlike opioids, which block pain by binding to receptors in the brain, Journavx targets proteins that trigger pain signals before they reach the brain. This different approach could reduce the risk of addiction.
“A key factor in developing medicines that don’t carry the addictive risks of opioid drugs is blocking pain signals before they reach the brain,” said Dr. David Altshuler of Vertex Pharmaceuticals in an interview with the Associated Press last year.
Despite its novel mechanism, Journavx is not without side effects. Patients in trials reported issues such as nausea, constipation, itching, rash, and headaches.
Challenges in Chronic Pain Treatment
Vertex’s research into pain-signaling proteins stemmed from studies on individuals with a rare hereditary condition that causes an inability to feel pain. The Boston-based pharmaceutical company has drawn interest from Wall Street for its ambitious drug pipeline, including efforts to develop non-opioid treatments for chronic pain—a much larger market than short-term pain relief.
However, the company faced a major setback in December when a mid-stage study of its chronic nerve pain treatment failed to show significant benefits over a placebo. The disappointing results sent Vertex’s stock price tumbling and raised concerns about the long-term viability of its pain management drugs.
What’s Next for Vertex?
Despite the setback, Vertex executives remain committed to their pain treatment pipeline. The company plans to launch a new, late-stage trial for its chronic pain medication, hoping that an improved trial design will yield better results and help secure FDA approval.
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