Ventrus Biosciences announced top line efficacy and safety results from the second Phase 3 clinical trial of Diltiazem Hydrochloride 2% Cream, or VEN 307 in patients with pain related to anal fissure. VEN 307 efficacy was as expected; placebo effect greater than anticipated, resulting in no significant difference between treatments. Data demonstrate an excellent safety profile. The company plans to request pre-NDA meeting with FDA to determine next steps. In this randomized double blind trial comparing diltiazem 2% cream versus placebo cream in 434 subjects in 90 centers globally, both treatment arms demonstrated a clinically meaningful improvement. The diltiazem 2% treatment arm demonstrated no significant improvement compared to placebo in the primary endpoint of average of worst anal pain associated with or following defecation. The mean of worst AF-related pain score at baseline was 7.09 for diltiazem 2% and 7.18 for placebo, decreasing to 3.81 and 3.72 respectively. Outcomes for the secondary endpoints of overall AF-related pain and PGI-I parallel the primary endpoint. Age, gender, and race were equivalent between arms, and results were not meaningfully different between countries. Inasmuch as a primary purpose of this second Phase 3 trial was to complete the safety data package for a New Drug Application (NDA) with the FDA, Ventrus will request a pre-NDA FDA meeting to determine next steps in the program. Because diltiazem is approved in oral formulations for the treatment of angina and high blood pressure, VEN 307 is eligible for the FDA's 505(b)2 registration pathway.
- Health Care Industry
- Pharmaceuticals & Drug Trials
- placebo effect
- Diltiazem Hydrochloride