Indantadol: Preliminary Phase IIb data
Top-line data from the international Phase IIb IN-STEP trial in 162 patients with neuropathic pain due to diabetes showed that twice-daily V3381 missed the primary endpoint of significantly reducing mean pain scores from baseline vs. placebo (p-value not disclosed). Specifically, V3381 led to a 25% reduction in pain scores from baseline vs. an undisclosed percent reduction for placebo. V3381 was generally well tolerated with dizziness as the most common adverse event reported. Vernalis said that although a full analysis of the data is ongoing, the company is unlikely to conduct further studies with V3381 to treat neuropathic pain due to diabetes. However, the company does plan to complete an ongoing pilot trial of V3381 to treat chronic cough. ...