Today, Clinical Data, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved vilazodone HCl tablets to be marketed under the brand name Viibryd™. A new molecular entity and the first and only selective serotonin reuptake inhibitor and 5HT1A receptor partial agonist, Viibryd will be used to treat adults with major depressive disorder (MDD). The company plans to make Viibryd available in U.S. pharmacies before June 30th of this year.
“When treating MDD, our goal is to offer treatment options that meet the individual needs of each patient,” stated 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 efficacy of Viibryd as a treatment for MDD was established in two 8-week, multicenter, randomized, double-blind, placebo-controlled studies in adults who met the specified criteria. In these studies, patients were titrated over two weeks to a dose of 40 mg of Viibryd once daily. Viibryd was superior to placebo in the improvement of depressive symptoms as measured by the mean change from baseline to week 8 in the Montgomery-Asberg Depression Rating Scale (MADRS) total score.
“While there are currently available treatments for MDD, no one therapy works for every patient and side effect profiles vary, which may impact both compliance and treatment success,” commented Carol R. Reed M.D., Executive Vice President and Chief Medical Officer of Clinical Data. “Viibryd will be a new choice for healthcare providers and their patients who are suffering from depression.”
“Viibryd is the only antidepressant that is a selective serotonin reuptake inhibitor and 5HT1A receptor partial agonist,” concluded Drew Fromkin, President and CEO of Clinical Data. “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.”