Indevus' Sanctura XR approved by US FDA

The USA's Indevus Pharmaceuticals says that Sanctura XR (trospium Cl extended-release capsules) has been approved by the Food and Drug Administration. The drug is indicated for the once-daily treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.

Sanctura XR, the once-daily formulation of Sanctura, is a quaternary ammonium compound and belongs to a class of anticholinergic agents 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.

David Staskin, associate professor of urology, obstetrics and gynecology at Weill-Cornell Medical College, USA, and a lead investigator of a Phase III clinical study of Sanctura, noted that the efficacy of the prior formulation is preserved as well as the lack of metabolic drug-drug interactions, while the dry mouth rate is half of the prior formulation. "Sanctura XR offers physicians a unique quaternary amine as a once-daily treatment option for patients whose quality of life is significantly affected by bladder control issues," he added.