Vertex Pharmaceuticals’ drug candidate is an oral selective NaV1.8 pain signal inhibitor that targets moderate to severe acute pain, according to a July 30 news release.
The FDA has given the drug its fast-track and breakthrough therapy designations, and priority review. Vertex said it expects a decision by Jan. 30, 2025.
In trials, suzetrigine demonstrated a favorable benefit/risk profile for patients with moderate to severe pain, and the drug was well tolerated.
Some acute pain patients forgo medication because of worries of becoming dependent on opioids, according to Scott Weiner, MD, chair of Vertex acute pain steering committee and an emergency physician at Brigham and Women’s Hospital in Boston.
“I look forward to the potential of having a new class of acute pain medicine — the first in more than two decades — to use as an alternative to opioids to help the millions of people impacted by acute pain,” Jessica Oswald, MD, an emergency medicine physician at UC San Diego Health and an acute pain steering committee member at Vertex, said in a news release about phase 3 results.
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