Viibryd (vilazodone hydrochloride) was approved by the U.S. Food and Drug Administration Monday to treat major depression — also known as clinical depression — in adults.
Viibryd is a one-of-a-kind drug for the treatment of depression that in clinical trials had fewer sexual side effects than other antidepressants. It works by way of a novel dual mechanism of action as both a potent and selective serotonin reuptake inhibitor (SSRI) and a partial agonist of the 5-hydroxytryptamine 1a (5-HT1A) receptor. Viibryd is therefore able to combine first-line therapy for depression with 5-HT1A partial agonism, an accepted add-on treatment for depression and a common initial treatment for anxiety disorders.
“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.
Unlike traditional SSRIs, the company-funded Phase III clinical trials found that sexual function in patients was comparable to placebo when measured by an objective sexual functioning scale. Many older SSRI antidepressant medications have been associated with causing or exacerbating sexual dysfunction.
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.
The drug will be available in 10, 20 and 40 milligram tablets.
Clinical 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.
Viibryd is manufactured by PGxHealth, New Haven, Conn.
Source: U.S. Food and Drug Administration