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Monday, January 24, 2011

Viibryd Approved To Treat Major Depressive Disorder

Clinical Data, Inc. (NASDAQ: CLDA), and FDA announced today that  Viibryd has been approved for treating major depressive disorder (MDD). The Food And Drug Administration, FDA has approved Viibryd tablets (vilazodone hydrochloride) to treat major depressive disorder (MDD) in adults. Major Depression, the other term for Major Depressive Disorder, interfere with a person's ability to work, sleep, study, eat, and enjoy once-pleasurable activities.
“Major depressive disorder is disabling and prevents a person from functioning normally, Medications affect everyone differently, so it is important to have a variety of treatment options available to patients who suffer from depression.” according to Thomas Laughren, M.D., director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research.
"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." said Stephen M. Stahl, M.D., Ph.D., Professor of Psychiatry, University of California, San Diego.

Viibryd was demonstrated to be safe in clinical studies. In the placebo-controlled, Phase III studies, the most commonly observed adverse reactions in Viibryd-treated patients were diarrhea, nausea, vomiting and insomnia. No single adverse event led to discontinuation of treatment in greater than 1% of patients. Overall, 7.1% of the patients who received Viibryd discontinued treatment due to an adverse reaction, compared to 3.2% of placebo-treated patients. Viibryd has not been associated with any clinically important changes in laboratory test parameters including liver function tests, ECG including QT interval, or vital signs. In addition, Viibryd had no effect on body weight as measured by mean change from baseline in the 8-week studies. Among the common adverse reactions (≥2%) related to sexual function with Viibryd compared to placebo were decreased libido (4% vs. <1%), abnormal orgasm (3% vs. 0%), delayed ejaculation (2% vs. 0%, males only), and erectile dysfunction (2% vs. 1%, males only).1


Viibryd (vilazodone hydrochloride) is manufactured by PGxHealth, New Haven, Conn.
Clinical Data, Inc. (NASDAQ: CLDA),


For Immediate Release: Jan. 21, 2011
Media Inquiries: Sandy Walsh, 301-796-4669; sandy.walsh@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA approves Viibryd to treat major depressive disorder
The U.S. Food and Drug Administration today approved Viibryd tablets (vilazodone hydrochloride) to treat major depressive disorder in adults.
Major depressive disorder, also called major depression, is characterized by symptoms that interfere with a person's ability to work, sleep, study, eat, and enjoy once-pleasurable activities. Episodes of major depression often recur throughout a person's lifetime, although some may experience only a single occurrence.
Signs and symptoms of major depression include: depressed mood, loss of interest in usual activities, significant change in weight or appetite, insomnia or excessive sleeping (hypersomnia), restlessness/pacing (psychomotor agitation), increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and suicide attempts or thoughts of suicide. All people with major depression do not experience the same symptoms.
“Major depressive disorder is disabling and prevents a person from functioning normally,” said Thomas Laughren, M.D., director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. “Medications affect everyone differently, so it is important to have a variety of treatment options available to patients who suffer from depression.”
The most frequent adverse reactions reported by patients taking Viibryd in clinical trials included diarrhea, nausea, vomiting, and insomnia.
The drug will be available in 10, 20 and 40 milligram tablets.
Viibryd and all other antidepressant drugs have a boxed warning and a patient medication guide describing the increased risk of suicidal thinking and behavior in children, adolescents, and young adults ages 18 to 24 during initial treatment.
The warning also says data did not show this increased risk in adults older than 24 and that patients ages 65 and older who take antidepressants have a decreased risk of suicidal thinking and behavior. The warning says depression and other serious psychiatric disorders themselves are the most important causes of suicide and that close monitoring of patients starting these medications is necessary.
Viibryd is manufactured by PGxHealth, New Haven, Conn.
For more information:
FDA: Antidepressant Use in Children, Adolescents, and Adults1
National Institute of Mental Health: Depression2

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