BioCentury
ARTICLE | Regulation

Vertex heads into new commercial territory with pain approval

FDA approves biotech’s Journavx, ushering in a new therapeutic mechanism for pain management

January 31, 2025 2:28 AM UTC

FDA’s approval of Vertex’s acute pain medicine Journavx suzetrigine ushers in the first new therapeutic mechanism for pain management in ages. Whether Vertex can turn that scientific breakthrough into commercial success depends both on launch execution and its ability to expand the drug’s label into larger opportunities in chronic pain. 

Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) said Thursday that FDA granted approval of the Nav1.8 inhibitor to treat adults with moderate-to-severe acute pain, a broad label that could apply to pain that swells up after any type of tissue injury or surgery. The approval was based on two Phase III studies in post-surgical pain. The company is positioning the therapy as a measure that can be taken when NSAIDs and acetaminophen aren’t enough, but before turning to opioids. The hope is that the priority to stem the opioid crisis outweighs budget constraints...

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