The US Food and Drug Administration (FDA) has approved PGxHealth’s Viibryd tablets (vilazodone hydrochloride) for the treatment of major depressive disorder in adults.
Major depressive disorder, also called major depression, is characterised by symptoms that interfere with a person’s ability to work, sleep, study, eat, and enjoy once-pleasurable activities.
The tablets will be available in 10mg, 20mg and 40mg.
The most frequent adverse events reported by patients participating in clinical trials of Viibryd included diarrhoea, nausea, vomiting, and insomnia.
Viibryd and all other antidepressants have a boxed warning and a patient medication guide explaining the increased risk of suicidal thinking and behaviour in children, adolescents, and young adults aged 18-24 during initial treatment.
Thomas Laughren, director of the division of psychiatry products at the FDA’s Center for Drug Evaluation and Research, said that 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,” Laughren added.