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news.Indevus Pharmaceuticals's Sanctura XR has been approved by the FDA for once- daily treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.
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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 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,” said said David Staskin, a lead investigator of the Phase III clinical study.
The FDA approval was based on a review of data from clinical studies conducted across the US involving approximately 1,300 subjects. Indevus said that the drug was well tolerated. The most commonly reported side effects in Phase III US trials were dry mouth (10.7% for Sanctura XR vs 3.7% for placebo) and constipation (8.5% for Sanctura XR vs 1.5% for placebo).