Diltiazem cream: Phase III data

Top-line data from a double-blind, international Phase III trial in 434 patients with anal fissures showed that thrice-daily 2% diltiazem cream missed the primary endpoint of reducing the average of worst anal pain associated with or following defecation from baseline to week 4 vs. placebo (3.28 vs. 3.46 points). Ventrus said the efficacy of diltiazem cream was "as expected," but that the placebo effect was "greater than anticipated." Adverse events were similar between treatment arms, with gastrointestinal disorders reported as the most common adverse events. The company plans to request a pre-NDA meeting with FDA to determine next steps. ...