Ventrus Biosciences Gets FDA Written Feedback, Anounces NDA Filing for Diltiazem (VEN 307)
Ventrus Biosciences (NASDAQ: VTUS) today announced that, following the receipt of written feedback from the U.S. Food and Drug Administration (FDA), the Company expects to file a new drug application (NDA) for diltiazem hydrochloride cream (VEN 307) in anal fissures following completion of a second Phase 3 study. Ventrus has started to enroll in its second Phase 3 pivotal trial, with results expected early fourth quarter 2013, and assuming a successful outcome, expects to file an NDA late in the fourth quarter of 2013 with an anticipated PDUFA date at the end of 2014. Ventrus also received specific guidance on the remaining toxicology programs, clinical cutaneous safety studies, and PK study required for the NDA and all programs are underway.
The second pivotal Phase 3 trial, a Phase 3b, Randomized, Double-Blind, Placebo-Controlled, Parallel-Treatment Group, Multicenter Efficacy and Safety Study of Topical Diltiazem Hydrochloride 2% Cream in Subjects with Anal Fissure, is planned to enroll 400 subjects at approximately 120 clinical sites in