logo
Share SHARE
FONT-SIZE Plus   Neg

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 RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Apple has upgraded the data storage option for its online storage service iCloud Drive, now offering 2 terabytes of space for $19.99 a month. The move reportedly indicates a new storage tier for the upcoming iPhone 7, which is set to be launched on September 7, along with the larger iPhone 7 Plus. Shares of Karyopharm Therapeutics Inc. (KPTI) soared over 36% on Tuesday after the company said it will provide an overview of top-line results from its Phase 2b study for oral Selinexor in multiple myeloma, dubbed STORM, on September 6, 2016. Chipotle Mexican Grill (CMG) is giving away free food and drinks this September as the restaurant chain still struggles to boost its sales that has been sluggish after outbreaks of E.coli, salmonella and norovirus at its restaurants. The chain is offering free kids meals every Sunday in September...
comments powered by Disqus
Follow RTT