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news.Biotech firm Indevus Pharmaceuticals has successfully piloted its bladder drug Sanctura XR in a phase II study, which established the efficacy of the drug when administered once a day as opposed to the marketed twice daily formulation known simply as Sanctura.
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Not only did the new once daily formulation of Sanctura improve all the symptoms and signs of overactive bladder, it was also was very well tolerated among the 148 patients with overactive bladders recruited to the study.
The two-week multi-centered trial was placebo-controlled and double-blind in nature. The methodology included the daily measurement of common symptoms of overactive bladder, such as urgency, frequency and incontinence episodes. Volume voided was collected at the last two days of each week. In addition, several quality of life assessments were collected.
The magnitude of improvement compared to 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 and constipation.
A phase III study is scheduled to begin in the summer of 2005. The company anticipates filling for the drugs approval with the FDA later next year.
Following the release of this positive data, shares in Indevus jumped by over 6%.