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Ventrus Biosciences' diltiazem cream improves pain, promotes healing in anal fissures study

Monday, May 14 2012 | Comments
Evidence Grade 0 What's This?
Ventrus Biosciences Inc.'s diltiazem hydrochloride topical cream achieved the main endpoint in a Phase III trial of patients with anal fissures by significantly improving pain as compared with placebo.

The study included 465 patients who were randomized to receive diltiazem 4% or 2% cream or placebo. Treatment was applied topically three times daily for eight weeks, followed by a four-week blinded observation period.

Relative to placebo, both doses of diltiazem cream demonstrated significant improvements from baseline in the average of the participants' worst anal pain associated with or following defecation during week four, as well as significant improvements in the secondary endpoints of overall anal fissure-related pain and healing of anal fissures.

The three treatment arms had a similar number of reported adverse events.

S.L.A. Pharma AG, Ventrus' development partner, conducted the study. Ventrus holds rights to diltiazem cream in North America.

Based on the study results, Ventrus said it would request a meeting with the Food and Drug Administration to discuss a Phase III study of the product and the steps required to proceed toward submitting a New Drug Application (NDA). The firm is also preparing to start a second pivotal late-stage trial of diltiazem cream in patients with anal fissures in the second half of the year.

Because diltiazem hydrochloride is already approved in oral and injectable formulations for cardiac-related conditions, Ventrus said the NDA for the cream formulation would be eligible for submission under the FDA's 505(b)(2) regulations, which permit the use of historical data for a drug's already-approved components in the approval process so the drug can be approved more efficiently.

Shares of Ventrus closed at $12.58, up $1.62, or 14.8 percent, in heavy volume on the Nasdaq.

This information concerns a use that has not been approved by the FDA.

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