The new drug application includes the results of the company's phase III clinical program as well as the results of additional phase I and phase II studies.
Indevus co-promotes Sanctura with its partner, Esprit Pharma, which will also market Sanctura XR upon approval in the US. Indevus licensed trospium chloride from Madaus GmbH, which markets the product for overactive bladder in multiple countries outside the US.
Sanctura and Sanctura XR belong to a class of anticholinergic compounds known as muscarinic receptor antagonists. These compounds relax detrusor smooth muscle tissue found in the bladder, decreasing bladder contractions. Overactive or unstable detrusor muscle function is believed to be the cause of overactive bladder.