FDA approves once-daily treatment for overactive bladder

August 17, 2007

The FDA has approved trospium chloride extended-release capsules (Sanctura XL) for once-daily treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.

The FDA has approved trospium chloride extended-release capsules (Sanctura XL) for once-daily treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.

The FDA approval was based on a review of data from clinical studies conducted across the United States involving approximately 1,300 patients. The drug was well tolerated, and the most commonly reported side effects in phase III trials were dry mouth (10.7% for extended-release trospium vs. 3.7% for placebo) and constipation (8.5% vs. 1.5%).

“The introduction of Sanctura XR will provide overactive bladder patients an efficacious treatment combined with excellent tolerability,” said lead author David R. Staskin, MD, of New York Presbyterian Hospital and Weill-Cornell Medical College, New York. “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.”