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SLA Pharma completes enrollment for Diltiazem Phase 3 trial

SLA Pharma has completed patient enrollment and randomization in the first Phase 3 trial of Diltiazem (VEN 307) in patients with anal fissures.

Ventrus Biosciences has licensed the North American rights to diltiazem hydrochloride cream from SLA Pharma.

Initial top-line data from the randomized, double-blind study is expected to be available in May 2012, the company said.

The placebo-controlled trial will evaluate the safety and efficacy of diltiazem hydrochloride cream in subjects with anal fissure and is being conducted in 31 centers in Europe.

The primary endpoint will evaluate the change from baseline in the average of worst anal pain associated with or following defaecation for Week 4.

Ventrus chairman and CEO Russell Ellison said the company reached an important milestone in the clinical development of diltiazem cream.