FDA ACCEPTS INDEVUS' NDA FOR SANCTURA XR

Indevus Pharmaceuticals announced that the FDA has accepted for review its new drug application (NDA) for Sanctura XR (trospium choloride), a once-daily formulation of Sanctura, for the treatment of overactive bladder. The FDA Prescription Drug User Fee Act target action date for Sanctura XR is Aug. 13, 2007.

The NDA includes the results of the company's Phase III clinical program as well as the results of additional Phase I and Phase II studies. The previous NDA for Sanctura is also referenced for supportive data.

In addition to this clinical database, more than 700,000 prescriptions for Sanctura have been written since the launch of the product in 2004. Indevus co-promotes Sanctura with its partner, Esprit Pharma, which will also market Sanctura XR in the U.S. upon approval. Indevus licensed trospium chloride from Madaus GmbH, which markets the product for overactive bladder in multiple countries outside the United States.

Sanctura belongs to a class of anticholinergic compounds known as muscarinic receptor antagonists. These compounds relax detrusor 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.