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Clinical Data submits antidepressant with companion Dx

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Clinical Data submits its NDA for vilazodone, a dual-acting selective serotonin reuptake inhibitor and a 5-HT1A receptor partial agonist, for the treatment of major depressive disorder. In two eight-week Phase III trials, vilazodone was superior to placebo, with statistical significance for the primary and multiple secondary endpoints. Vilazodone would be set apart on the market by the availability of a companion diagnostic to identify patients most likely to benefit from treatment. Clinical Data is co-developing the test along with the drug. It estimates that peak sales could surpass $2 billion with the companion diagnostic (1"The Pink Sheet" DAILY, April 8, 2009)

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