Vilazodone submission set for 2009
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Newton, Mass.-based Clinical Data expects to file an NDA for its depression candidate vilazodone in 2009, the firm says Dec. 17. A long-term safety study initiated ahead of schedule in December, along with a second pivotal Phase III trial expected to begin in early 2008, will support the NDA for the dual serotonergic agent, which was licensed from Merck KGaA in September 2004. The second pivotal trial will evaluate a pharmacogenetic test developed in the recently completed first pivotal trial to assist physicians in predicting patients' response to vilazodone...
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