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Indevus trospium for OAB

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Indevus submits an NDA for its oral antimuscarinic agent trospium for the treatment of overactive bladder April 28. A Phase III pivotal trial, presented at the American Urological Association April 28, showed statistically significant results for the dual pre-specified endpoints of reduction in frequency of urination (toilet voids) and reduction in number of urge incontinence episodes. At week 12, trospium patients had 2.37 fewer toilet voids per day than at baseline, versus 1.29 for placebo. Incontinence episodes were reduced 59% in trospium patients versus 44% in placebo patients. Indevus is claiming a favorable side effect profile; 21.8% of trospium patients experienced dry mouth and 9.5% experienced constipation in the pivotal trial. Trospium is currently marketed in Europ

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