NEW YORK (GenomeWeb News) – Clinical Data said today it has initiated a long-term safety study for its depression treatment drug Vilazodone.
The company said the safety study will support a new drug application it expects to file with the US Food and Drug Administration in 2009. The study will test the long-term safety and tolerability of Vilazodone and will enroll patients at 40 sites in the US.
Clinical Data is developing a pharmacogenetic test that would be used to determine the chances of Vilazodone working for a particular patient.
Company CEO Drew Fromkin said the genetic test for Vilazodone will “help clinicians more quickly and confidently identify patients who are likely to respond, leading to improvements in patient care and outcomes.”
In addition to the safety study, Clinical Data said it is planning a second Phase III trial that will continue to evaluate genetic biomarkers of Vilazodone response that it identified in a previous trial, which met its primary and supportive secondary endpoints for efficacy of Vilazodone in the treatment of major depressive disorder.