Silke Mayr The US Food and Drug Administration (FDA) approved suzetrigine, a groundbreaking non-opioid pain reliever, on Thursday. This marks the first approval of a new pain medication class in 25 years. Sold under the brand name Journavx, the drug is a 50-milligram tablet taken every 12 hours after an initial higher dose.
“This non-opioid option can reduce opioid risks and expand pain management choices,” said Dr. Jacqueline Corrigan-Curay, acting director at the FDA’s Center for Drug Evaluation and Research. The FDA expedited suzetrigine’s development and review to prioritize safe opioid alternatives. Studies reveal that painkillers are the most prescribed drugs in hospitals, with millions of Americans filling pain prescriptions annually. Opioids, which carry risks of addiction, remain a significant part of these prescriptions.
Suzetrigine’s approval is the first since the anti-inflammatory drug Celebrex in 1998. Unlike opioids, suzetrigine blocks pain signals before they reach the brain, preventing pain nerves from firing. Dr. Sergio Bergese from Stony Brook University explained that pain occurs when nerve cells transmit damage signals to the brain, but this drug stops the signal pathway.
“This drug halts pain transmission without producing a high,” Bergese noted, emphasizing that it lacks the addictive potential of opioids.
From Discovery to FDA Approval
Suzetrigine’s development began with a remarkable family in Pakistan who could walk on hot coals due to a rare genetic mutation. This mutation blocked pain-conducting nerves while leaving other sensations like heat and touch unaffected. “They felt the heat but not the pain,” explained Stuart Arbuckle, Vertex Pharmaceuticals’ chief operating officer.
Researchers spent 25 years developing suzetrigine by targeting sodium channels that transmit pain signals. Dr. Stephen Waxman from Yale described how neurons use electrical impulses—regulated by these sodium channels—to communicate. Suzetrigine blocks a specific channel responsible only for pain signals. Although previous attempts to create similar drugs failed, suzetrigine’s success opens doors for future innovations.
“This proves that sodium-channel blockers can relieve pain, paving the way for more advanced treatments,” said Waxman, who has no financial stake in the drug.
Suzetrigine comes in a two-dose regimen. Participants in clinical trials took a 100-milligram starter dose, followed by 50 milligrams every 12 hours. Researchers found that it reduced post-surgical pain as effectively as Vicodin, though direct comparisons between the two weren’t made.
Trial participants reported pain reductions of about 3.5 points on a 10-point scale. “It’s not complete pain relief but about a 50% reduction,” Arbuckle explained. However, a smaller trial on sciatica-related back pain showed no significant improvement over a placebo, leading to questions about its effectiveness for chronic pain.
Vertex remains confident, asserting that suzetrigine has shown promise for chronic pain conditions like diabetic neuropathy. In this condition, high blood sugar damages nerves, causing pain, numbness, and weakness. Arbuckle acknowledged that smaller trials and high placebo effects can complicate pain research results but believes the drug performed as expected.
A New Tool in Pain Management
Pain specialists are eager to integrate suzetrigine into treatment plans. “The more options, the better we can tailor care to each patient,” said Dr. Kimberley Mauer from Oregon Health and Science University. However, she noted that the drug’s price and insurance coverage could impact accessibility. Vertex set the wholesale price at $15.50 per pill and plans to offer financial assistance for patients.
“Cost might limit access initially,” Mauer cautioned, adding that doctors and patients would need time to see how insurance companies respond.
Despite these uncertainties, suzetrigine offers a new, non-addictive option for pain relief—one that experts hope will lead to safer and more effective pain treatments in the future.