About Depression
Vilazodone, a novel dual-acting serotonergic antidepressant, is a selective and potent serotonin reuptake inhibitor and a partial agonist of the 5-hydroxytryptamine 1a (5-HT1A) receptor. Clinical Data acquired worldwide exclusive rights to develop and market vilazodone from Merck KGaA, now Merck Serono.

According to the World Health Organization (WHO), depression was the leading cause of disability as measured by years lived with disability (YLDs) and the fourth leading contributor to the global burden of disease disability adjusted life years (DALYs) in 2000. By the year 2020, depression is projected to reach second place in the ranking of DALYs calculated for all ages and both sexes. Depression will also be the second largest killer after heart disease by 2020 -- and studies show depression is a contributory factor to fatal coronary disease. In addition, according to the National Institute of Mental Health (NIMH), Major Depressive Disorder is the leading cause of disability in the U.S. for ages 15-44 and affects approximately 18.1 million American adults.

NIMH estimated the cost of depression in the United States in the year 2000 to be $83 billion, including $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. In addition, NIMH reports at least 66% of all suicides are preceded by depression.

About Vilazodone
Vilazodone, a new chemical entity, is a potent and selective serotonin reuptake inhibitor and a partial agonist of the serotonin 1a (5-HT1A) receptor in development for the treatment of major depressive disorder (MDD). We have completed two, randomized, double-blind, placebo-controlled Phase III clinical trials in which vilazodone was shown to be superior to placebo in improvement of symptoms of depression and on overall improvement. In these studies, vilazodone was also shown to be safe and well-tolerated. Discontinuation rates due to adverse events were low. The most common adverse events associated with vilazodone treatment were diarrhea, nausea and insomnia and considered mild to moderate in intensity. In addition, vilazodone’s impact on sexual function was shown to be similar to placebo when measured by quantitative, validated scales. Patient-reported adverse events related to sexual function, although infrequent, were more common on vilazodone than placebo. Vilazodone was also superior to placebo in improvement of symptoms of anxiety associated with major depressive disorder. A New Drug Application (NDA) for was accepted for standard review by the FDA on May 21, 2010 with a PDFUA date of January 22, 2011.

To find out more about Vilazodone and related opportunities, please e-mail Clinical Data, Inc.’s PGxHealth division at info@PGxHealth.com, or call toll-free at 1-877-2-PGXHEALTH (877-274-9432).