ARTICLE | Product Development
The big biotech is seeking ways to prevent placebo responses in a chronic pain indication it hopes will grow the market for its non-opioid painkiller
By Paul Bonanos, Director of Biopharma Intelligence
December 19, 2024 10:25 PM UTC
Vertex is considering innovative trial designs in planned Phase III trials of a non-opioid analgesic it has long seen as a key potential growth driver, after the therapy generated disappointing results in a Phase II program for a chronic pain indication.
Data released early Thursday showed that although suzetrigine (VX-548) met the Phase II study’s primary endpoint by reducing pain scores from baseline, the reductions matched those of a placebo arm relative to its baseline (-2.02 points, p<0.0001 vs. -1.98 points, p<0.0001). The trial evaluated the small molecule Nav1.8 inhibitor’s effect on the numeric pain rating scale (NPRS) in patients with sciatica, known formally as lumbosacral radiculopathy, and was not designed to compare suzetrigine with placebo directly…
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- Source: https://www.biocentury.com/article/654531/after-analgesic-disappoints-in-phase-ii-vertex-looking-at-innovative-pivotal-designs