Because it works outside the brain by a different mechanism than opioids, the new medication offers a safe alternative to opioids, which can be highly addictive.

For its approval, the FDA relied on data from two randomized, double-blind, placebo- and active-controlled trials on patients who were recovering from surgeries—either tummy tucks (abdominoplasty) or bunion removal. Patients had access to ibuprofen as a “rescue” pain medication. Both trials showed that suzetrigine led to clinically meaningful reductions in pain and was safe.