Just as many branded antidepressants are going off patent, Clinical Data arrived on the scene with the first new drug for the treatment of major depression, or major depressive disorder (MDD), to receive FDA approval in a decade.
Vilazodone hydrochloride, marketed as Viibryd, received FDA approval on Jan. 21, 2011. Vilazodone is a dual action selective serotonin reuptake inhibitor (SSRI) and serotonin 1A receptor partial agonist. Forest Labs purchased Viibryd from Clinical Data following the FDA's approval.
Clinical Data reported that vilazodone performed comparably to other antidepressants in phase 3 clinical trials but did not share side effects that are common in other approved depression treatments such as sexual dysfunction and significant weight gain. Side effects that did appear with vilazodone were insomnia, nausea, vomiting and diarrhea.
Did the industry need another antidepressant? According to the FDA and psychiatric experts, many patients are dissatisfied with the first treatment for depression and often are prescribed different medications until they find one that helps.
“Major depressive disorder is disabling and prevents a person from functioning normally,” said Thomas Laughren, MD, director of the FDA’s Division of Psychiatry Products, 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 drug was approved at 10, 20 and 40 milligram tablet doses.
As with all antidepressants, the FDA requires that vilazodone include a boxed warning and patient guide explaining that the drug carries an increased risk for suicide in children, adolescents, and young adults 18 to 24 years old when beginning treatment.
"While there are currently available treatments for MDD, no one therapy works for every patient and side effect profiles vary, which may impact both compliance and treatment success," said Carol R. Reed MD, Clinical Data’s chief medical officer, in a press statement. "Viibryd will be a new choice for healthcare providers and their patients who are suffering from depression."
The World Health Organization estimates that about 18 million Americans suffer from major depression. More than 212 million prescriptions were written for antidepressants in 2009, according to a report by pharmaceutical industry analyst, IMS Health.
Pristiq, which was approved in 2008 for the treatment of depression in adults, was a modified version of Wyeth’s Effexor XR.