The second pivotal Phase 3 trial, a randomized, double-blind, placebo-controlled, parallel-treatment group, multicenter efficacy and safety study of VEN 307 in subjects with AF, enrolled 434 subjects and is being conducted at 90 global clinical sites, with the majority of sites and patients located in
The study's primary objective is to evaluate the efficacy of VEN 307 on reduction of worst AF-related pain associated with or following defecation when administered three times a day (TID) for 28 days. The secondary objectives are to evaluate the effect of VEN 307 on reduction of overall daily AF-related pain and to evaluate patient global impression of improvement (PGI-I) at Day 29 in subjects with AF-related pain. To be eligible for randomization into the study, all patients had to have sufficient baseline AF-related pain associated with or following defecation of ≥ 5 on an 11-point numerical rating score (NRS) scale with 0 being no pain and 10 being the worst possible pain.
"This is an important milestone in the clinical development of VEN 307, and marks completion of enrollment in the second of two pivotal clinical trials for the treatment of anal fissures," said Dr.
Because diltiazem is approved in oral formulations for the treatment of angina and high blood pressure, VEN 307 is eligible for the
About VEN 307: Diltiazem Hydrochloride Cream
Diltiazem hydrochloride is a calcium-channel blocker that has been marketed in oral formulations for the treatment of angina and high blood pressure for over two decades. Diltiazem hydrochloride cream is applied perianally to treat pain related to anal fissure. It has been shown to normalize internal anal sphincter pressure and reduce anal maximal resting pressure, or MRP, and its vasodilator activity has the potential to improve blood supply, thereby decreasing the pain associated with anal fissures.
About Anal Fissures
Anal fissure is a tear in the lining of the anal canal characterized by severe anal pain associated with or after bowel movements. It is a common anal disorder, which we believe is underdiagnosed. The pathogenesis of anal fissure is hypothesized to be initiated by the passage of a hard fecal bolus, resulting in a split in the epithelium of the anal canal. Along with poor vascular supply of the anal epithelium, increased activity (tone) of the internal anal sphincter smooth muscle further compromises the anodermal blood supply and contributes to the pain and ischemia of the anal epithelium, perpetuating ulceration and preventing healing.
In 2010, it was estimated by
Ventrus is a specialty pharmaceutical company primarily focused on the development and commercialization of prescription drugs addressing gastrointestinal problems. The Company's lead product, topical diltiazem (VEN 307) for the treatment of anal fissures, reported positive top line results in
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Ventrus Biosciences, Inc. David Barrett646-706-5208 email@example.com Argot Partners David Pitts212-600-1902 firstname.lastname@example.org
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