The U.S. Food and Drug Administration (FDA) has approved Journavx (suzetrigine) 50 mg oral tablets as a new treatment for acute pain conditions, offering effective relief for adults experiencing moderate to severe pain. Journavx alleviates pain by targeting a pain-signaling pathway that involves sodium channels in the peripheral nervous system (PNS), preventing pain signals from reaching the brain.
Through its distinct mechanism of action, this drug reduces the risk of addiction, and the side effects associated with opioids. This innovative approach opens the possibility to transform acute pain treatment by providing safer alternatives for millions of patients.
The primary treatment approach for acute pain resulting from surgeries, injuries, and accidents often involves the use of opioid medications. More than 80 million Americans take pain medication annually, and among these, approximately 40 million receive opioids. However, around 10% of patients develop opioid use disorders, highlighting the risks associated with prolonged opioid use. Inadequate pain management leads to chronic discomfort, reduce quality of life, and increase healthcare costs.
Journavx received FDA approval for its acute surgical pain therapy based on two clinical trials. These studies included patients who were undergoing abdominoplasty and bunionectomy. In both trials, patients were required additional pain management with ibuprofen. The experimental group receiving Journavx experienced statistically significant pain reduction compared to the placebo group.
Clinical data on Journavx’s safety was derived from the analysis of two major trials, double-blind, placebo- and active-controlled, including 874 patients with additional safety information from an open-label study assessing 256 patients with acute pain conditions. The most frequently reported adverse effects in both studies were muscle spasms followed by rashes, elevated creatine phosphokinase levels, and itching. Journavx should not be used with potent CYP3A inhibitors, and patients are advised to avoid grapefruit or grapefruit juice, as it may alter the drug’s effectiveness.
The recent approval marks a valuable milestone for the 80 million Americans who experience moderate to severe acute pain and undergo treatment annually, said Dr. Reshma Kewalramani, who leads Vertex Pharmaceuticals as CEO and President. The first-in-class non-opioid pain signal inhibitor Journavx represents a new major class of pain medications for more than 20 years that enables fundamental acute pain treatment changes while fostering a new standard of care.
Jacqueline Corrigan-Curay, J.D., M.D., acting director of the FDA’s Center for Drug Evaluation and Research, stated, “Developing a new class of non-opioid analgesics for acute pain offers the potential to reduce some of the risks associated with opioids while offering patients another treatment choice.
Vertex Pharmaceuticals is also advancing suzetrigine as a potential treatment for peripheral neuropathic pain. Currently, the company is developing a Phase 3 pivotal program in painful diabetic peripheral neuropathy patients, with the expansion of research to include painful lumbosacral radiculopathy, pending regulatory discussions.
Journavx approval is the first step toward reducing opioid dependency and improving patient outcomes. As research continues, it may be one of the pioneering innovations leading to breakthroughs in managing acute pain.
Reference: Food and Drug Administration. FDA Approves Novel Non-Opioid Treatment for Moderate to Severe Acute Pain. Published January 30, 2025. Accessed February 3, 2025. FDA Approves Novel Non-Opioid Treatment for Moderate to Severe Acute Pain | FDA
Vertex. Vertex Announces FDA Approval of JOURNAVX™ (suzetrigine), a First-in-Class Treatment for Adults With Moderate-to-Severe Acute Pain. Published January 30, 2025. Accessed February 3, 2025. https://news.vrtx.com/news-releases/news-release-details/vertex-announces-fda-approval-journavxtm-suzetrigine-first-class
