The US Food and Drug Administration has informed Solvay that its selective serotonin reuptake inhibitor Luvox (fluvoxatine) has been granted approvable status in the USA for the treatment of obsessive compulsive disorder.
The drug is available in 36 countries (including most of Europe and Canada) for the treatment of depression and/or OCD, and was recommended for approval by the FDA's Psychopharmacological Drugs Advisory Committee for the treatment of OCD last October.
The committee's decision was based on the results of two 10-week trials in OCD sufferers. The results showed that of patients achieving a 25%-50% improvement on the Yale Brown Obsessive Compulsive Scale, 33% were taking fluvoxamine compared to 16% taking placebo. In addition, 43% of patients in the fluvoxamine arms were classed as "much improved" or "very much improved" as measured by the Global Clinical Improvement Scale.
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