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news.Clinical Data has initiated a long-term safety study for Vilazodone, for the treatment of depression, ahead of schedule. Along with a second pivotal Phase III trial that is on track to begin in the company's fiscal fourth quarter, ending on March 31, 2008, this safety study is intended to support a new drug application for Vilazodone expected to be filed with the FDA in 2009.
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This current study will test the long-term safety and tolerability of Vilazodone and will enroll patients at 40 sites in the US. A second pivotal trial will continue the evaluation of genetic biomarkers of response to Vilazodone that were identified in the first pivotal trial announced by the company in September 2007.
Drew Fromkin, president and CEO of Clinical Data, said: “By launching this trial, Clinical Data continues to demonstrate its ability to independently move a promising compound through the development process. We are encouraged by the results of our recently completed pivotal study of Vilazodone, which suggests that it has important benefits as a stand-alone compound for patients with depression. With the addition of a genetic test for response to Vilazodone, we can help clinicians more quickly and confidently identify patients who are likely to respond, leading to improvements in patient care and outcomes.”