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FDA OKs Viibryd to Treat Depression

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Updated: 1/25/2012 5:11 pm

Jan. 26, 2011 -- The FDA has approved a new drug called Viibryd to treat adults with major depressive disorder.

Carol Reed, MD, chief medical officer of Clinical Data Inc., tells WebMD that Viibryd offers a new choice for doctors treating people with depression. It is the only antidepressant that is a selective serotonin reuptake inhibitor but also works as a 5HT1A receptor partial agonist, meaning it affects the brain chemical serotonin in two ways. Serotonin helps regulate mood and other processes.

“Major depressive disorder is disabling and prevents a person from functioning normally,” Thomas Laughren, MD, director of the division of psychiatry products in the FDA’s Center for Drug Evaluation and Research, says in a news release.  “Medications affect everyone differently, so it is important to have a variety of treatment options available to patients who suffer from depression.”

New Treatment Option

Stephen M. Stahl, MD, PhD, professor of psychiatry at the University of California, San Diego, says in a news release that Viibryd “is an important new treatment option with proven efficacy and a demonstrated safety profile.”

In the clinical trials, Viibryd was superior to placebo in the improvement of depressive symptoms.

Viibryd was associated with adverse reactions including diarrhea, nausea, vomiting, and insomnia in some patients during clinical trials.

Other adverse effects of Viibryd included decreased libido in 4% of study participants compared to less than 1% in those taking a placebo. Erectile dysfunction was reported by 2% of study participants on Viibryd compared to 1% in people on placebo.

Like all other antidepressant medications, the drug will contain a boxed warning and a patient medication guide describing the potentially increased risk of suicidal thinking and behavior in children, adolescents, and young adults 18 to 24 during initial treatment.

The FDA says in a news release that the warning in Viibryd prescriptions also will say that data did not show an increased of suicidal thoughts in adults older than 24, and decreased risk of suicidal thinking and behavior in patients 65 and older.

Clinical Data Inc. states in a news release that it plans to make Viibryd available in the U.S. in the second quarter of this year.

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