FDA approves first new non-opioid pain pill in 20 years—how it works
LOS ANGELES - The FDA has approved Journavx, a non-opioid pain medication developed by Vertex Pharmaceuticals, marking the first new pharmaceutical approach to pain relief in over two decades.
The drug is designed to provide an alternative to opioids, which have long been associated with addiction and overdose risks.
What is Journavx?
Big picture view:
Journavx is the first FDA-approved pain medication in decades that does not rely on opioid receptors to manage pain. Instead, it blocks proteins responsible for triggering pain signals before they reach the brain.
This makes it a potentially safer alternative to opioids, which are highly addictive and have fueled the ongoing opioid epidemic.
The drug is designed for short-term pain relief, particularly for patients recovering from surgery or injuries. Common side effects include nausea, constipation, itching, rash, and headaches, but unlike opioids, it does not carry a risk of addiction.
How effective is it?
What they're saying:
Journavx has shown mixed results in clinical trials. In studies involving more than 870 patients recovering from foot and abdominal surgeries, it provided better pain relief than a placebo but did not outperform a common opioid-acetaminophen combination pill.
"It’s not a slam dunk on effectiveness," said Michael Schuh, a pharmacist and 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."
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A sign for the Food And Drug Administration is seen outside of the headquarters on July 20, 2020 in White Oak, Maryland. (Photo by Sarah Silbiger/Getty Images)
Despite its potential, some experts note that it may not offer the same level of pain relief as opioids, which could limit its adoption by doctors and patients.
How much does it cost?
The list price for Journavx is set at $15.50 per pill, making it significantly more expensive than generic opioids, which often cost as little as $1 per pill. While opioids come with a risk of addiction and overdose, their affordability has contributed to their widespread use in pain management.
The high cost of Journavx could be a barrier to widespread adoption, though supporters argue that its benefits outweigh the financial burden.
What's next:
While Journavx is currently approved for acute pain relief, Vertex Pharmaceuticals is working on expanding its use for chronic pain. However, the company’s stock plummeted in December after a clinical trial failed to show significant benefits in treating chronic nerve pain.
Despite this setback, Vertex executives remain optimistic, planning a new study to test whether changes in trial design could yield better results. If successful, the drug could become a broader alternative to opioids for long-term pain management.
The Source: This report is based on information from the Associated Press and the U.S. Food and Drug Administration.