FDA approves Viibryd to treat major depressive disorder

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FDA NEWS RELEASE

For Immediate Release: Jan. 21, 2011

Media Inquiries: Sandy Walsh, 301-796-4669; sandy.walsh@...

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 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.â€

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 Adults

National Institute of Mental Health: Depression

 

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Page Last Updated: 01/21/2011

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