Solvay Gains Luvox Approval From FDA

Solvay Pharmaceuticals has received approval from the US Food and Drug Administration for its antipsychotic Luvox (fluvoxamine maleate) to treat obsessive-compulsive disorder. The drug will be marketed jointly by Solvay and Upjohn.

Luvox was granted approvable status by the FDA in September depending upon labelling and marketing plans (Marketletter September 12). The approval was granted on the basis of two ten-week trials in OCD sufferers which showed that of patients achieving a 25%-50% improvement on the Yale Brown Obsessive Compulsive scale, 33% were taking fluvoxamine compared to 16% on placebo.

The most common side effects associated with the use of Luvox were somnolence, insomnia, nervousness, tremor, nausea, dyspepsia, anorexia and vomiting. The product is contraindicated for use with terfenadine (Marion Merrell Dow's Seldane) or astemizole (Johnson & Johnson's Hismanal). The contraindication is due to a theoretical possibility of cardiovascular side effects.