Vilazodone
In 2003, about 18.8 million American adults suffered from depressive illness. However, since only one-half to two-thirds of patients who require treatment for their depression respond to the current first-line treatment option, Selective Serotonin Reuptake Inhibitors (SSRIs), many are forced to try more than one medication before they experience relief from their symptoms. Typically, patients with these disorders must be treated for weeks to months before their symptoms are meaningfully reduced. During this time, patients and their families suffer the consequences of uncontrolled disease, which may include lost time from work, unwanted side effects of the therapeutic, drug-drug interactions and lack of compliance due to poor or no response. All of these undesirable effects result in increased cost of care and burden to the healthcare system.

By targeting therapy based on genetics, the likelihood of response can be increased. Thus, the right drug will be prescribed the first time, giving patients and their care givers increased confidence that a positive response will be achieved. This should result in increased compliance, less switching, improved physician and patient satisfaction and decreased cost of care.

With this in mind, Clinical Data acquired worldwide exclusive rights to develop and market vilazodone from Merck KGaA. This compound has a novel dual mechanism of action, acting as both a potent selective serotonin-reuptake inhibition (SSRI) and as a 5-HT1A partial agonist, suggesting it may be more effective than currently available SSRIs. Clinical Data initiated the first pivotal trial for vilazodone in February 2006 in which genetic biomarkers for response to vilazodone will be identified. Results from this study will be available in mid-2007. We expect to perform at least one additional pivotal trial before an NDA Filing which could occur by end of year 2009.

Vilazodone is being developed as a targeted antidepressant through use of a genetic test that is being developed in parallel with the pivotal trials and developed by PGxHealth. This test will be able to predict if a patient is likely to respond to vilazodone. Physicians believe that this strategy will both improve compliance and increase response rates, which should result in decreased cost of care. This will position vilazodone as a unique product in the treatment of depression, a product that can be targeted to an individual patient’s needs.

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