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.
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.”
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
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.