DOLIZEM

DOLIZEM (VEN 307) is a topical 2% diltiazem hydrochloride cream developed by Ventrus Biosciences for the treatment of pain associated with anal fissures. Diltiazem is a calcium-channel blocker that works by normalizing internal anal sphincter pressure and reducing maximal resting pressure. Its vasodilatory properties also improve local blood flow to the affected area, which aids in the healing process and alleviates pain. The drug was developed via the FDA's 505(b)(2) regulatory pathway, leveraging the established safety profile of oral diltiazem. Despite achieving statistical significance in its first Phase 3 clinical trial, a second Phase 3 trial failed to meet the primary endpoint due to a high placebo response, leading to the termination of the development program for this indication.

Brand names

DOLIZEM

Other names

Diltiazem Hydrochloride 2% Cream