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news.Watson Pharmaceuticals, a specialty pharmaceutical company, has received the FDA approval for Rapaflo, the company's new alpha blocker for the treatment of the signs and symptoms of benign prostatic hyperplasia.
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The approval is based on data from two Phase III, 12-week, randomized, double-blind, placebo-controlled, multi-center studies as well as a 40 week open label study.
In the two Phase III studies, 923 patients (mean age 64.6 years) were randomized to receive either Rapaflo 8mg once-daily or placebo. In the two trials, 8mg once-daily Rapaflo for 12 weeks resulted in significant and rapid relief of benign prostatic hyperplasia (BPH) symptoms, compared with placebo, as measured by the International Prostate Symptom Score (IPSS).
Paul Bisaro, CEO of Watson, said: “Rapaflo’s approval is the most important milestone for the company’s brand division thus far. Rapaflo is a novel product that provides strong efficacy and an exceptional safety profile for patients managing their BPH. Rapaflo provides an excellent long term opportunity for Watson and will be the foundation for future growth of our urology franchise.”