FDA accepts for review new drug application for trospium
LEXINGTON, MASS., June 30, 2003 -- Indevus Pharmaceuticals announced that the FDA has accepted for review the company's New Drug Application (NDA) for trospium for the treatment of overactive bladder (OAB).
The NDA for trospium includes the results of 32 clinical studies involving over 2,700 subjects and patients, including 12 double-blind, placebo- or active-controlled studies, 12 clinical pharmacology and pharmacokinetic studies and 8 uncontrolled studies.
Trospium belongs to a class of anticholinergic compounds known as muscarinic receptor antagonists. These compounds relax smooth muscle tissue found in the bladder, thus decreasing bladder contractions. Overactive or unstable detrusor muscle function is believed to be the cause of overactive bladder.
Source: Indevus Pharmaceuticals, Inc.
Posted: June 2003