Indevus Pharmaceuticals has announced that a second late-stage clinical trial for its extended-release overactive bladder treatment, Sanctura, backs efficacy data from an earlier study.
The company said a second Phase III trial showed that Sanctura XR reduced the average number of incidents of patients urinating before being able to reach a restroom by 83 percent, compared with a 52 percent reduction in patients given placebo. At 12 weeks, Sanctura XR patients went to the bathroom an average 2.5 fewer times per day, compared with 1.8 fewer times per day in the placebo group. Results were statistically significant.
The study enrolled 564 patients at 62 clinical sites, with 280 patients given Sanctura XR and 284 patients given placebo.
In mid-June, the company released similar results from another Phase III study. Indevus plans to file an application with the FDA by the end of the year.