About Depression
Vilazodone, a novel dual-acting serotonergic antidepressant, is a potent and selective serotonin reuptake inhibitor (SSRI), 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
In February 2006, Clinical Data initiated its first Phase III trial of vilazodone for the treatment of Major Depressive Disorder (MDD). This was a randomized, double-blind, placebo-controlled trial conducted at ten U.S. centers, with enrollment of 410 subjects. The results results from trial were published in March 2009 in the Journal of Clinical Psychiatry (JCP). In this study, the primary endpoint of superiority of vilazodone compared to placebo was achieved, with a P value of 0.001. A separate editorial, published in the March issue of the journal Personalized Medicine, reports additional research completed as part of the Phase III study, and describes examples of genetic biomarkers predictive of individual response to vilazodone.

A second Phase III study began enrollment in March 2008 with positive topline results announced in June 2009. The second Phase III study was a randomized, double-blind, placebo-controlled trial of 481 patients with MDD conducted at 12 U.S centers. Similar to the first Phase III study, vilazodone demonstrated statistically significant results for the study’s primary endpoint and secondary efficacy endpoints, including the Montgomery-Åsberg Depression Rating Scale (MADRS), Hamilton Depression Rating Scale (HAMD17), and the Hamilton Anxiety Scale (HAMA).

Both of these Phase III studies suggested that vilazodone was generally well-tolerated with the most frequent adverse events being diarrhea, nausea, and headache. A new drug application (NDA) for vilazodone is anticipated to be submitted during the first quarter of calendar 2010.

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