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NDA Submitted for Vilazodone for the Treatment of Major Depressive Disorder
“This is a major milestone in the development of vilazodone and, if approved, its dual mechanism of action and safety profile will offer a new alternative for patients suffering from depression,” said Carol R. Reed, M.D., Executive Vice President and Chief Medical Officer of Clinical Data. “We are very encouraged by the results seen to date in vilazodone’s clinical development and look forward to working with the Agency during the review process.”
The NDA submission is based on a comprehensive development program for vilazodone, which includes two randomized, double-blind, placebo-controlled Phase III clinical trials. In both of these eight-week trials, the efficacy of vilazodone was substantiated as shown by its superiority to placebo, with statistically significant results for the primary and multiple secondary endpoints. Results from efficacy measures in an uncontrolled long-term safety study were consistent with these findings. In Phase III studies, most adverse events were mild to moderate in intensity and consistent with vilazodone’s expected pharmacologic effect; the most common adverse reactions included diarrhea, nausea and insomnia. Typically, these adverse reactions occurred early in treatment and did not result in discontinuation of treatment with vilazodone. Overall, vilazodone has been shown to have a good safety profile and to be well tolerated in a database of nearly 2,900 patients treated for up to 52 weeks.
“This is an extraordinary accomplishment for Clinical Data to complete our NDA submission for vilazodone and to meet our goal by delivering it to the FDA this quarter, as promised,” said Drew Fromkin, Clinical Data’s President and Chief Executive Officer.
Depression is a highly prevalent mood disorder with significant morbidity and mortality. The National Institute of Mental Health estimates that major depressive disorder affects approximately 18.1 million adults in the U.S. and that the medical and social costs of depression in the U.S. in the year 2000 was $83 billion, including both $26 billion in costs of treatment and $57 billion in losses such as absenteeism, reduced productivity at work, and the value of lifetime earnings lost due to suicide-related deaths. Further, approximately 60% of MDD patients have a comorbid psychiatric condition, including anxiety-related disorders and posttraumatic stress disorder.1 Despite advances in the understanding of pharmacotherapy and the ongoing development of new agents, overall effectiveness is unsatisfactory and approximately two-thirds of patients do not achieve remission with first-line treatment.2 More than 212 million prescriptions were written for antidepressants in 2009, with commonly prescribed agents accounting for approximately $12 billion.3
Vilazodone is a novel, dual-acting potent and selective serotonin reuptake inhibitor and a 5-HT1A receptor partial agonist in development for the treatment of major depressive disorder. Selective serotonin reuptake inhibitors, which enhance the availability of synaptic 5-HT, are approved as safe and effective treatments for depression and 5-HT1A receptor partial agonists have been shown to be effective for mood disorders including depression and anxiety. The efficacy of vilazodone in the treatment of MDD has been substantiated as shown by its superiority to placebo in two randomized, Phase III clinical trials. Results of an uncontrolled long-term safety study were consistent with the findings of the placebo-controlled studies. Vilazodone is currently not approved by the FDA.
Source: Clinical Data, Inc.