logo
Plus   Neg
Share
Email

Ventrus Announces Results From Phase 3 Trial Of VEN 307 In Patients With AF

Ventrus Biosciences Inc. (VTUS) 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 or AF.

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 (-3.28 difference) and 3.72 (-3.46 difference) 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.

The company stated that Adverse events (AEs) were similar for the two treatment arms. Gastrointestinal disorders were the most common with 20.7% of patients in the diltiazem 2% arm versus 21.9% in the placebo arm, substantially less than reported in the first Phase 3 trial. Reports of headaches were 5.1% for diltiazem 2% and 1.9% for placebo. There was one serious adverse event of pregnancy.

In the first pivotal Phase 3 trial, the diltiazem 2% treatment arm demonstrated a statistically significant improvement compared to placebo in the primary endpoint of average of worst anal pain associated with or following defecation.

Inasmuch as a primary purpose of this second Phase 3 trial was to complete the safety data package for a New Drug Application or NDA with the FDA, Ventrus said it 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.

by RTTNews Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
In a move likely to further inflame global trade tensions, President Donald Trump has threatened to impose a 20 percent tariff on all cars imported to the U.S. from the European Union. Trump claimed he would impose the new tariffs unless the EU removes tariffs and trade barriers placed on the U.S. The Federal Reserve has determined that the largest U.S. banks are strongly capitalized and would be able to lend to banks as well as households during a severe global economic recession. This is the fourth straight year that all banks have met the Federal Reserve's standards. The first round of results of the supervisory stress tests were released by the central bank on Thursday. The "safety" driver behind the wheel of a self-driving Uber was streaming a television show on her smartphone up until about the time of a fatal crash in March, according to a report from the Tempe Police Department. Uber's self-driving Volvo SUV, which was traveling at under 44 miles per hour, had struck and killed a pedestrian in Arizona on March 18.
Follow RTT