FDA Approval: Viibryd

Clinical Data, Inc. (NASDAQ: CLDA), today announced that the U.S. Food and Drug Administration (FDA) has approved vilazodone HCl tablets, to be marketed under the brand name Viibryd™, for the treatment of adults with major depressive disorder (MDD). Viibryd is a new molecular entity and the first and only selective serotonin reuptake inhibitor and 5HT1A receptor partial agonist. Clinical Data plans to make Viibryd available in U.S. pharmacies in the second quarter of this year.

“It is also the first drug that the Company has developed, and to have received marketing approval from the FDA on its first review is a significant milestone for Clinical Data.”

“When treating MDD, our goal is to offer treatment options that meet the individual needs of each patient,” said Stephen M. Stahl, M.D., Ph.D., Professor of Psychiatry, University of California, San Diego. “Viibryd is an important new treatment option with proven efficacy and a demonstrated safety profile.”

The mechanism of the antidepressant effect of Viibryd is not fully understood but is thought to be related to its enhancement of serotonergic activity in the central nervous system (CNS) through selective inhibition of serotonin reuptake. Viibryd is also a partial agonist at serotonergic 5HT1A receptors; however, the net result of this action on serotonergic transmission and its role in Viibryd’s antidepressant effect are unknown.

For more information about recent drug approvals or pharmaceutical branding, please contact Vince Budd at vbudd@addisonwhitney.com