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Extended Release Trospium Chloride Cleared by FDA

LEXINGTON, Mass., Aug. 6 /PRNewswire-FirstCall/ -- Indevus Pharmaceuticals, Inc. (NASDAQ:IDEV) today announced that SANCTURA(R) XR (trospium chloride extended release capsules) has been approved by the U.S. Food and Drug Administration (FDA). Trospium chloride 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 compounds 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.

"The introduction of Sanctura XR will provide overactive bladder patients an efficacious treatment combined with excellent tolerability," said David R. Staskin, M.D., director, section of voiding dysfunction, New York Presbyterian Hospital and associate professor of urology and obstetrics and gynecology at Weill-Cornell Medical College and a lead investigator of the Phase III clinical study. "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."

Glenn L. Cooper, M.D., chairman and chief executive officer of Indevus stated, "SancturaXR sets a new standard for overactive bladder treatments with its overall efficacy and landmark tolerability. Receiving approval in advance of our PDUFA date is extremely gratifying and represents an important achievement for Indevus."

Overactive bladder is a medical condition whose symptoms include urinary frequency, urgency, and urge urinary incontinence, the accidental loss of urine that occurs after the strong, sudden urge to urinate. OAB is estimated to affect approximately 33 million Americans and represents a significant clinical problem with potential medical, hygienic, and social consequences. When untreated, this condition can lead to disability, dependence, and isolation from the community. It is most prevalent among the elderly and strikes women twice as frequently as men. It is estimated that the diagnosis and treatment costs associated with OAB exceed $32 billion annually, and based on the aging population and increasing human life expectancy, these costs are expected to grow significantly.

The FDA approval of Sanctura XR was based on a review of data from clinical studies conducted across the U.S. involving approximately 1,300 subjects. Sanctura XR was well tolerated, and the most commonly reported side effects in Phase III U.S. clinical trials were dry mouth (10.7 percent for Sanctura XR vs. 3.7 percent for placebo) and constipation (8.5 percent for Sanctura XR vs. 1.5 percent for placebo). Patients who have urinary retention, gastric retention, uncontrolled narrow-angle glaucoma or hypersensitivity to Sanctura XR should not use Sanctura XR.

Source: Indevus

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