Once-Daily Formulation for OAB Treatment Approved

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Sanctura XR (trospium chloride extended-release capsules), made by Indevus Pharmaceuticals, Inc., of Lexington, Mass., has been approved for the once-daily treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. This formulation is a quaternary ammonium compound belonging to a class of anticholinergic compounds known as muscarinic receptor antagonists, which relax smooth muscle tissue in the bladder and decrease bladder contractions. Unstable or overactive detrusor muscle function is believed to be the cause of OAB. The approval was based on a review of data from clinical studies across the United States, which found Sanctura XR to be well tolerated. “The introduction of Sanctura XR will provide OAB patients an efficacious treatment with excellent tolerability,” said David R. Staskin, MD, director of voiding dysfunction at New YorkPresbyterianHospital and lead investigator of a phase III clinical study of the new formulation. “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.” OAB is most prevalent among the elderly and strikes women twice as often as men.

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