FDA Approves Viibryd to Treat Major Depressive Disorder

On January 21, 2011, the FDA announced its approval of Viibryd (vilazodone hydrochloride) to treat major depressive disorder in adults. Viibryd is the first antidepressant that is a selective serotonin reuptake inhibitor combined with an 5HT1A receptor partial agonist. The drug will be available in 10 mg, 20 mg, and 40 mg tablets. “Major depressive disorder is disabling and prevents a person from functioning normally,” said Thomas Laughren, MD, director, Division of Psychiatry Products, Center for Drug Evaluation and Research, in a statement. “Medications affect everyone differently, so it is important to have a variety of treatment options available to patients who suffer from depression,” he added. In placebo-controlled, phase III studies, the most frequently reported adverse reactions with Viibryd included 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 with 3.2% of placebo-treated patients. Viibryd has not been associated with any clinically important changes in laboratory test parameters (eg, liver function tests), QT interval prolongation, or vital signs. In addition, Viibryd had no effect on body weight as measured by mean change from baseline in the 8-week studies. In addition, unlike other antidepressants that may affect sexual function, no difference was observed in sexual functioning scores between the people taking Viibryd and those taking a placebo, indicating the drug may have fewer sexual side effects. As with all antidepressant medications, Viibryd includes a boxed warning outlining the increased risk of suicidal thinking and behavior in children, adolescents, and young adults between 18 and 24 years during initial treatment, but indicates that patients 65 years and older have a decreased risk of suicidal thinking and behavior. Regardless, the warning indicates that patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. In addition, families and caregivers should be advised of the need for close observation and communication with the prescriber. Viibryd is manufactured by PGxHealth, New Haven, CT, and is anticipated to become available this spring.