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Indevus Pharmaceuticals reports positive trial results for overactive bladder drug Sanctura XR
By Jennifer Chiou
New York, June 15 - Indevus Pharmaceuticals, Inc. announced promising feedback from a pilot study of Sanctura XR, an overactive bladder medication.
The two-week multi-center, placebo-controlled, double-blind study showed the new once-daily Sanctura XR has comparable efficacy to previous results of the currently marketed twice-daily Sanctura and is "well tolerated."
The Phase II study included monitoring the urgency, frequency and incontinence episodes of 148 patients with overactive bladders and found that Sanctura XR improved all of the symptoms and signs of overactive bladder.
The degree of improvement compared to the placebo was very similar to that observed with Sanctura in earlier studies. In addition, patients treated with Sanctura XR indicated they had an improved quality of life compared to the placebo-treated patients.
The most common anticholinergic side effects were dry mouth (8% of the placebo treated patients compared to 12% of the Sanctura XR-treated patients) and constipation (none reported in the placebo treated patients versus 2% of the Sanctura XR-treated patients).
"We are pleased that this pilot study demonstrated that Sanctura XR had an excellent efficacy and safety profile," said Glenn L. Cooper, president and chief executive officer, in a news release.
"We remain on schedule to initiate our Phase III program this summer with a goal of submitting an NDA in the second half of next year."
Lexington, Mass.-based Indevus Pharmaceuticals is a biopharmaceutical company engaged in the acquisition, development and commercialization of products targeting certain medical specialty areas, including urology and infectious diseases.
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