First Non-Opioid Treatment Approved for Acute Pain in Two Decades

For the first time in over twenty years, the U.S. Food and Drug Administration (FDA) approved a new type of pain relief medication, offering an alternative to traditional opioid treatments. The drug, suzetrigine, marketed as Journavx™, is approved to treat moderate to severe acute pain in adults. Our experts at Private Health Management (PHM) review what you need to know about this new class of pain medication.

A New Approach to Pain Management
Opioids are the most potent pain relievers but because they affect the central nervous system, they carry a high risk of addiction.¹ Opioid addiction and misuse drove a overdose epidemic in the U.S. between 1999 and 2017, highlighting the urgent need for effective, nonaddictive pain treatments. Suzetrigine relieves pain via a different mechanism than opioids. Pain signals travel like messages through electrical wires from the site of injury through the peripheral nervous system, up the spinal cord, and to the brain where the signals are interpreted as pain. Suzetrigine works like a selective circuit breaker, blocking a pain specific sodium channel, called Nav1.8, that is only found in peripheral nervous system tissue, to disrupt pain signals before they reach the brain, reducing pain without the risk of addiction.

Clinical Trials Demonstrate Efficacy and Safety
The FDA’s approval was based on two randomized, double-blind, placebo-controlled trials involving patients undergoing tummy tuck (abdominoplasty) and bunion removal (bunionectomy) surgeries.^2–4 Researchers tracked self-reported pain levels for 48 hours post-anesthesia. Suzetrigine led to significantly greater and faster pain reduction than placebo. In patients who had tummy tucks, 61% reported at least a 30% pain reduction versus 48% with placebo, while 83% of patients who had bunion surgery reached this threshold compared to 68% on placebo.² Suzetrigine was generally well tolerated. The most common side effects reported included nausea, headache, and dizziness.^2,3

Dosing and Other Considerations
Suzetrigine is taken orally, as a tablet, at a dose of 100mg twice a day. It should not be used with strong CYP3A inhibitors, and patients should avoid grapefruit products while taking it. As with any medication, weighing the benefits and risks with a healthcare professional is key.

A Step Forward in Pain Management
The role of suzetrigine in pain management is still uncertain, but experts recognize its promise for addressing more severe pain when over-the-counter options fall short. While opioids remain the standard for post-surgical pain relief, suzetrigine’s pain reduction rates (61% and 83% in trials) suggest it could be a viable alternative for many patients, with a significantly lower risk of dependence. It may have potential to become the preferred first-line treatment following surgeries and minor procedures, including dental work, replacing the opioids commonly prescribed today.

References

1. Volkow, N. D., Jones, E. B., Einstein, E. B. & Wargo, E. M. Prevention and Treatment of Opioid Misuse and Addiction: A Review. JAMA Psychiatry 76, 208–216 (2019).
2. Jones, J. et al. Selective Inhibition of NaV1.8 with VX-548 for Acute Pain. New England Journal of Medicine 389, 393–405 (2023).
3. JOURNAVX- suzetrigine tablet, film coated. Package insert. Vertex Pharmaceuticals Incorporated https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f0976da4-1d20-4517-945c-b60ed2f41c12 (2025).
4. Commissioner, O. of the. FDA Approves Novel Non-Opioid Treatment for Moderate to Severe Acute Pain. FDA https://www.fda.gov/news-events/press-announcements/fda-approves-novel-non-opioid-treatment-moderate-severe-acute-pain (2025).