Development stage pharmaceutical company Ventrus Biosciences Inc (VTUS) Monday released positive results from its Phase 3, randomized, double-blind, placebo-controlled clinical trial of diltiazem hydrochloride cream in patients with anal fissures.
Ventrus further added that its development partner S.L.A Pharma has completed most of the outputs for the statistical analysis plan of the Phase 3 trial,
Ventrus revealed that the Phase 3 study randomized 465 subjects to diltiazem hydrochloride 4% or 2% w/w cream, or placebo, applied topically three times daily for 8 weeks, followed by a 4 week blinded observation period.
The pharmaceutical company revealed that both 4% and 2% diltiazem treatment arms demonstrated significant improvements compared to placebo in the primary endpoint of average of worst anal pain associated with or following defecation and in the secondary endpoints of overall anal-fissure-related pain and anal fissure healing Pain endpoints were assessed using an 11-point numerical pain rating scale.
"These results mark a watershed event for Ventrus, in that they highlight the potential for VEN 307 to be a treatment of choice for anal fissures and set off a potentially transformative period for the Company," said Russell H. Ellison, M.D., M.Sc., Chairman and Chief Executive Officer of Ventrus Biosciences, Inc.
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