USA: On January 30, 2025, the U.S. Food and Drug Administration (FDA) approved suzetrigine, a new non-opioid pain medication, marking the first approval of its kind in two decades. Sold under the brand name Journavx and developed by Vertex Pharmaceuticals, the drug is designed to treat moderate-to-severe pain and is taken twice daily. According to an article published on Time.com by Alice Park, this approval represents a significant milestone in pain management, offering a potential alternative to opioids, which have been linked to addiction and overdose epidemics.
The Need for Non-Opioid Alternatives
Opioids have long been the most potent option for pain relief, but their risks are well-documented. From 1999 to 2017, overdose deaths involving prescription opioids increased more than sevenfold in the U.S., highlighting the urgent need for safer alternatives. Suzetrigine, as a non-opioid, avoids the addictive mechanisms of opioids, which bind to receptors in the brain and spinal cord. Instead, it targets sodium channels specific to pain neurons in peripheral tissues, offering a novel approach to pain relief.
How Suzetrigine Works
Suzetrigine operates by modulating sodium channels, which play a key role in pain transmission. The human body has nine sodium channels, each active in different tissues. Suzetrigine specifically targets the Nav 1.8 channel, which is found in pain neurons throughout the body but not in the brain. This selective targeting minimizes the risk of addiction.
Developing the drug was no small feat. As Paul Negulescu, senior vice president at Vertex, explained, “We screened hundreds of thousands of compounds looking for the needle in the haystack that inhibited 1.8.” After identifying the right compound, Vertex conducted animal studies and later human trials, which were completed in early 2024. The company submitted its FDA application in July of that year.
Clinical Trial Results
The efficacy of suzetrigine was tested in clinical trials involving patients with acute pain following bunion removal and tummy tuck surgeries. These procedures were chosen to represent pain from both bone and soft tissue injuries. Patients were randomly assigned to receive suzetrigine, hydrocodone-acetaminophen (an opioid), or a placebo.
Results showed that suzetrigine provided greater and faster pain relief compared to the placebo. For example, 61% of abdominoplasty patients taking suzetrigine reported at least a 30% reduction in pain, compared to 48% on the placebo. Among bunionectomy patients, 83% on suzetrigine achieved this threshold, versus 68% on the placebo.
While opioids provided better pain control, suzetrigine’s non-addictive nature makes it a promising alternative. Dr. Jessica McCoun, an anesthesiologist and principal investigator in the trials, noted, “We saw patients reporting huge decreases in pain.” She added, “The results make me believe that suzetrigine could replace opioid use, although I can’t say that for sure.”
Potential for Chronic Pain
Vertex is also exploring suzetrigine’s potential for chronic pain, though results have been less definitive. In a study of sciatica patients, both suzetrigine and placebo groups reported similar small reductions in pain after 12 weeks. Despite this, Negulescu remains optimistic. “Our belief is that the Nav1.8 mechanism is going to be relevant in both acute and chronic pain,” he said.
Chronic pain often involves complex mechanisms, such as damaged tissues or nerves. Negulescu explained that suzetrigine’s mechanism could be effective in both musculoskeletal and neuropathic pain, though further research is needed.
Implications for Pain Management
Suzetrigine’s approval could reshape how pain is managed, particularly in post-surgical and dental settings. While the drug does not eliminate pain entirely, it offers a safer alternative to opioids. “Patients still feel pain; they don’t go to zero pain sensation,” said Negulescu. However, he believes the drug represents a step toward more precise pain control.
Dr. Todd Bertoch, chief medical officer for pain research at CenExel, highlighted the drug’s safety profile. “This is the first study I have ever conducted where the side-effect profile for people on placebo was worse than the side-effect profile for people on the study drug,” he said.
A New Tool for Doctors
While opioids may still have a role in treating certain types of pain, suzetrigine provides a valuable addition to the pain management toolkit. As Bertoch noted, “Suzetrigine lets me add another tool that doesn’t have liver toxicity, doesn’t have kidney toxicity, is very safe, and is at least additive and maybe even synergistic with acetaminophen and ibuprofen.”
The drug’s approval is a significant development in the ongoing effort to address the opioid crisis while providing effective pain relief. As research continues, suzetrigine could become a first-line treatment for acute pain, offering hope for a safer future in pain management.
*All information and quotes in this article are sourced from an article by Alice Park published on *Time.com* on January 30, 2025.*
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