Ventrus Biosciences' (VTUS) Diltiazem Cream to treat patients with anal fissures improved their symptoms in a second Phase III trial, as expected.
However, the placebo effect in the control group was greater than anticipated, resulting in no significant difference between the treatments.
In the first pivotal Phase 3 trial, Diltiazem did perform better than the placebo.
Ventrus plans to request a pre-NDA meeting with the FDA to determine its next steps. (PR)