In the first of its kind, a new serotonin reuptake inhibitor with other unique functions has been approved by the FDA. The new drug, Viibryd, will be key in the treatment of adults diagnosed with major depressive disorder or MDD, and available to the public in 2011’s second quarter.

MDD is a mental disorder characterized by an imbalance of chemicals in the brain, also called neurotransmitters, and is one of the most common mental disorders in the United States. A person diagnosed with MDD exhibits a combination of symptoms that interfere with one’s ability to work, sleep, study, eat, and enjoy once pleasurable activities. Though an episode of depression may occur only once in a person’s life, it more commonly recurs throughout a person’s lifetime.

If manic, mixed, or hypomanic episodes develop, the diagnosis is changed to Bipolar Disorder. The World Health Organization estimates that MDD affects approximately 18 million people in the U.S. and more than 212 million prescriptions were written for antidepressants in 2009.

Stephen M. Stahl, M.D., Ph.D., Professor of Psychiatry, University of California, San Diego is excited about the new FDA approval:

“When treating MDD, our goal is to offer treatment options that meet the individual needs of each patient. Viibryd is an important new treatment option with proven efficacy and a demonstrated safety profile.”

The tablet form drug was approved for marketing by the FDA on January 21, 2011 for the treatment of MDD in adults. Clinical Data holds exclusive worldwide rights to Viibryd from Merck KGaA, Darmstadt, Germany. The safety of Viibryd was evaluated in 2,177 patients diagnosed with MDD.

Patients were given, over a two week period, 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. MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. It was designed in 1979 by British and Swedish researchers as an adjunct to the Hamilton Rating Scale for Depression (HAMD) which would be more sensitive to the changes brought on by antidepressants and other forms of treatment than the Hamilton Scale was.

Carol R. Reed M.D., Executive Vice President and Chief Medical Officer of Clinical Data states:

“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. Viibryd will be a new choice for healthcare providers and their patients who are suffering from depression.”

How exactly Viibryd truly works 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.

Drew Fromkin, President and CEO of Clinical Data concludes:

“Viibryd is the only antidepressant that is a selective serotonin reuptake inhibitor and 5HT1A receptor partial agonist. 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.”

Clinical Data is keen to point out that all patients treated with antidepressants should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the first few months of treatment and when changing the dose.

Source News Release: Clinical Data

Written By Sy Kraft, B.A.