Drug news

VEN 307 success Iin Phase III trial for Anal Fissure Pain

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Last updated:15th May 2012

Published:15th May 2012

Source: Pharmawand

VEN 307(diltiazem crean) from S.L.A.Pharma met the primary endpoint in a pivitol Phase III study, showing a statistically significant reduction in Anal Pain on defecation after four weeks compared to placebo. Both 4% and 2% diltiazem cream arms demonstrated statistically significant improvement over placebo for change in week four NRS for worst anal pain. Reduction in pain score was 0.44 (p=0.0108) and 0.42 (p=0.0134), for 4% and 2% diltiazem, respectively. Ventrus Bioscience holds the US rights to the drug and plans to meet with FDA officials to discuss the next steps toward filing an NDA. A further Phase III trial is planned for the autumn of 2012.

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