(EPICSTORIAN) – The U.S. Food and Drug Administration (FDA) has approved suzetrigine, the first new pain medication in more than two decades.
Developed by Vertex Pharmaceuticals, the drug offers a non-opioid alternative for treating acute pain and will be sold under the brand name Journavx.
Suzetrigine is taken every 12 hours following an initial higher dose. Unlike opioids, which alter pain perception in the brain, this medication blocks pain-signaling nerves before they send messages to the brain.
Dr. Jacqueline Corrigan-Curay, acting director of the FDA’s Center for Drug Evaluation and Research, highlighted the importance of the approval. “A new non-opioid analgesic for acute pain provides another treatment option while reducing certain risks associated with opioids,” she said. The FDA expedited its review, emphasizing the urgency of safer pain management solutions.
Breakthrough Inspired by Genetic Discovery
Scientists studying a family in Pakistan found they could walk across burning coals without experiencing pain. Researchers traced the phenomenon to a missing sodium channel in their nervous system, which prevented pain signals from being transmitted.
Stuart Arbuckle, chief operating officer at Vertex Pharmaceuticals, explained how suzetrigine works. “The drug blocks a specific sodium channel, stopping pain signals from reaching the brain while preserving other sensations,” he said.
Dr. Stephen Waxman, director of Yale’s Center for Neuroscience and Regeneration Research, called the approval a major step. “This validates the concept that targeting sodium channels can effectively reduce pain, opening the door for even more advanced treatments,” he said.
Clinical Trials and Effectiveness
FDA approval followed three clinical trials involving nearly 600 patients recovering from abdominal and foot surgeries. Suzetrigine controlled pain as effectively as Vicodin, a commonly prescribed opioid painkiller, but without the risk of addiction.
Pain levels were measured on a scale from 0 to 10, with participants initially reporting an average pain score of seven. Suzetrigine lowered those scores by about 3.5 points, matching the relief provided by opioid-based medications.
Another study focused on patients with sciatica-related back pain but found no significant difference between suzetrigine and a placebo. Vertex Pharmaceuticals remains confident in its potential for chronic pain conditions such as diabetic neuropathy and is continuing further research.
Pricing and Accessibility
Dr. Kimberley Mauer, an anesthesiologist at Oregon Health and Science University, welcomed the new option. “More choices allow doctors to tailor pain management to each patient,” she said. Insurance coverage and pricing, however, could affect accessibility.
Vertex Pharmaceuticals has set a wholesale price of $15.50 per 50-mg pill and plans to offer financial assistance programs. Mauer noted that insurance policies will determine how widely the drug can be prescribed. “It’s uncertain how coverage will work, and cost may limit access for some patients,” she said.
Reducing Opioid Dependency
Opioid addiction remains a major public health crisis. Medical professionals view suzetrigine as a step toward safer pain management, though it may not be suitable for every condition.
FDA approval of this medication signals progress in the search for non-addictive pain relief. Ongoing research may lead to even more effective alternatives, offering hope for millions in need of safer treatment options.
