Vertex Pharmaceuticals announced results from its Phase 2 study of suzetrigine, an investigational oral NaV1.8 pain signal inhibitor, in patients with painful lumbosacral radiculopathy (LSR). The study met its primary endpoint, showing a statistically significant and clinically meaningful 2.02 point within-group reduction from baseline in the Numeric Pain Rating Scale (NPRS) at Week 12.
However, the placebo arm in the study demonstrated a similar within-group reduction of -1.98 in NPRS, indicating no statistical separation between suzetrigine and placebo. The study was not designed or powered for a direct statistical comparison between the two arms.
Suzetrigine was generally well tolerated, with an incidence of adverse events of 22.9% in the active arm compared to 32.4% in the placebo arm. Vertex plans to advance suzetrigine into pivotal development for painful LSR, pending discussions with regulators, and will incorporate trial design innovations to better control for the placebo response in future studies.
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