INDEVUS FILES NDA FOR ONCE-DAILY OVERACTIVE BLADDER DRUG

Indevus Pharmaceuticals has submitted a new drug application (NDA) to the FDA seeking approval for Sanctura XR to treat patients with overactive bladder. Sanctura XR is the once-daily formulation of Sanctura (trospium chloride), which is currently marketed for overactive bladder.

The NDA submission follows the announcement of positive results from two Phase III trials conducted for Sanctura XR in overactive bladder. Both trials met their primary endpoints and key secondary endpoints. In addition, the company believes that the drug has set a new tolerability benchmark for oral drugs in the treatment of overactive bladder with an overall dry mouth incidence of 10.7 percent in the Phase III trials.

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, over 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 upon approval in the United States. Indevus licensed trospium chloride from Madaus GmbH, which markets the product in multiple countries outside the United States.