In a major development for pain management, the U.S. Food and Drug Administration has approved suzetrigine (Journavx), a new prescription pain medication developed by Vertex Pharmaceuticals. The drug is the first new pain killer approved in more than two decades and offers a safer alternative to opioids. Suzetrigine targets a specific sodium channel involved in pain signaling and is being praised for its unique mechanism of action, which could revolutionize how doctors treat acute pain following surgery or injury.
To learn more, Bottom Line Health spoke with Steven P. Cohen, MD, professor of anesthesiology and pain medicine at Northwestern University Feinberg School of Medicine.
No risk of dependence
Unlike traditional opioids, which affect the brain and carry a high risk of dependence, suzetrigine’s mechanism of action involves selectively blocking the Nav1.8 sodium channel. This channel is one of several sodium channels that play a key role in both inflammatory and neuropathic pain. By targeting Nav1.8 and avoiding the off-target effects of other sodium channel receptors in the brain and heart, suzetrigine offers a much cleaner safety profile, with no risk of addiction. This unique mechanism also makes it compatible with opioids, allowing for combination therapy that could reduce the amount of opioid medication needed.
For acute pain only, for now
While the drug is currently approved only for acute pain, studies are ongoing to evaluate its effectiveness in chronic conditions like sciatica. In one trial, the drug performed no better than a placebo for sciatica, though further research is needed.
If future studies are positive, suzetrigine will join a growing list of non-opioid medications—including gabapentin, duloxetine, and tricyclic antidepressants—already recommended for neuropathic pain in clinical guidelines. These drugs work through emotional and neurological pathways, helping modulate how pain is perceived by the brain. How well suzetrigine works for chronic non-neuropathic pain conditions resulting from tissue damage such as osteoarthritis, is still not known.
Availability timeline
Although suzetrigine has cleared FDA approval, patients may have to wait to access it. Healthcare providers say the path from approval to prescription is complex. Hospitals will need to add it to formularies, pharmacies must stock it, and insurance companies will likely impose cost-related restrictions. Because new pain killers like this often carry a high price tag, widespread access to suzetrigine may take several months. A panel is expected to meet in the coming weeks to finalize updated treatment guidelines for acute back pain, which could influence prescribing decisions. However, given the lack of clinical studies evaluating suzetrigine for acute back pain, a recommendation is unlikely.
Bottom line
Suzetrigine may not immediately replace opioids, but it represents a meaningful shift toward safer, more targeted pain killers. As Vertex prepares for a broader launch, healthcare providers are hopeful this approval will signal the start of a new era in pain treatment—one where effectiveness and safety go hand in hand.
