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FDA approves Clinical Data depression drug

Clinical Data has received marketing approval from the US Food and Drug Administration for Viibryd, a treatment for major depressive disorder

Clinical Data, Inc. has received marketing approval from the US Food and Drug Administration (FDA) for Viibryd (vilazodone) as a treatment for major depressive disorder, meaning depression that is severe enough to be disabling and prevent a person from functioning normally.

Vilazodone, which has been approved only for use in adults, is a dual-acting selective serotonin reuptake inhibitor and a 5-HT1A receptor partial agonist. Clinical Data expects the drug to be available in US pharmacies in the second quarter of this year in 10mg, 20mg and 40mg tablets.

"Medications affect everyone differently, so it is important to have a variety of treatment options available to patients who suffer from depression," said Thomas Laughren, director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research, in announcing the new approval.

The approval was based on two eight-week phase III clinical trials in which vilazodone was shown to be more effective than placebo in improving depressive symptoms as measured by the mean change from baseline in the Montgomery-Asberg Depression Rating Scale.

In the phase III studies, the most common adverse reactions were diarrhoea, nausea and insomnia. The reactions generally occurred early in treatment and did not result in discontinuation. An uncontrolled long-term safety study had results consistent with the phase III findings, the company said. The drug has been shown to be well-tolerated in a database of nearly 2,900 patients treated for up to 52 weeks, according to Clinical Data.

Like other antidepressant drugs, Viibryd will carry a boxed warning regarding the risk of suicidal thinking and behaviour in children, adolescents, and young adults up to the age of 24.

The product is the first drug to be developed by Clinical Data, which also has a phase III drug candidate called Stedivaze in development as a pharmacologic stress for use in myocardial perfusion imaging, as well as drugs entering the clinic in areas including asthma, ophthalmology and diabetes.

Clinical Data was originally a diagnostics company but has been transforming itself into a pharmaceutical company through a series of acquisitions and divestitures. Most recently, in 2010, the company sold its genetic and pharmacogenomic testing and biomarker development business to Transgenomic for $15.4m.

24th January 2011

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