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NEW YORK, Sept. 11, 2013 (GLOBE NEWSWIRE) -- Ventrus Biosciences, Inc. (Nasdaq:VTUS), a pharmaceutical company focused on developing and commercializing gastrointestinal products, today announced positive results from two clinical dermal safety studies and one pharmacokinetic (PK) study of diltiazem hydrochloride 2% cream (VEN 307). All three studies were conducted to support the Company's planned New Drug Application (NDA) for VEN 307 as a treatment for anal fissures (AF).
For the dermal safety studies, Ventrus conducted two single-center, randomized, controlled trials to evaluate the irritation and sensitization potential of VEN 307 in healthy volunteers. The studies utilized cumulative as well as repeat insult patch designs, which aim to provide a standard assessment of cutaneous tolerability and safety. In these studies, results demonstrated that VEN 307 was safe and well tolerated. Irritation and sensitization caused by VEN 307 was similar to that seen with both placebo and saline, and was significantly better than that seen with sodium lauryl sulfate (SLS), the positive control. Minimal adverse events (AE) and no severe or serious AEs were reported.
The Company also announced results from a pharmacokinetic (PK) study comparing VEN 307 to oral diltiazem in subjects with anal fissure. All PK parameters, including AUC, Cmax, Tmax and half-life, were consistent with expectations, and results demonstrated that systemic exposure of VEN 307 was approximately only 10% that of oral diltiazem, in line with prior data from an investigator sponsored trial with this product, and confirming a potentially high safety margin.
"These results mark another important step in our effort to develop and commercialize VEN 307 as a treatment for anal fissures," said Russell H. Ellison, M.D., M.Sc., Chairman and Chief Executive Officer of Ventrus Biosciences, Inc. "With enrollment in our second, pivotal Phase 3 study moving toward completion, we remain focused on conducting a high-quality trial with the appropriate patient population and rigorous inclusion/exclusion criteria. We have added several new clinical sites in Europe to help expedite screening and enrollment, and now expect to complete enrollment near the end of this year, with data expected in the first quarter of 2014. Based on our anticipated timeline, we believe we remain sufficiently capitalized to support operations through a potential launch of VEN 307."