logo
Share SHARE
FONT-SIZE Plus   Neg

Ventrus Biosciences Unveils Positive Results Of Its Phase 3 Trial Of Diltiazem

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.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Packaged food producer ConAgra Brands Inc. reported Thursday higher net profit in its fourth quarter with margin strength. Net sales, meanwhile, declined from last year on weak volume. Looking ahead, for fiscal 2018, the company projects higher adjusted earnings and lower to flat sales. The company also reiterated its three-year fiscal 2020 financial algorithm. Best Buy announced Wednesday its plans to introduce Amazon Alexa and Google Home experiences to its 700 locations across the U.S. starting next month as part of its strategy of pushing smart home technology. A nationwide rollout will be complete by the end of the year. The electronics retailer will expand space at selected stores to better showcase how Amazon's Echo and Google Home interact.. So far this year, 23 novel drugs have already received FDA approval. Now let's take a look at the biotech stocks waiting to hear from the FDA in July.
comments powered by Disqus
Follow RTT