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FDA Approves Silodosin for the Treatment of Benign Prostatic Hyperplasia NEW YORK -- October 9, 2008 -- The US Food and Drug Administration (FDA) has approved silodosin (Rapaflo) for the treatment of benign prostatic hyperplasia (BPH) symptoms. The approval is based on data from 2 randomised, double-blind, placebo-controlled, phase 3 trials lasting 12 weeks, and one 40-week open label study. In the 2 phase 3 studies, 923 patients (mean age 64.6 years) were randomised to receive either silodosin 8 mg QD or placebo. Results from both trials showed that silodosin 8 mg QD for 12 weeks resulted in significant and rapid relief of BPH symptoms, compared with placebo, as measured by the International Prostate Symptom Score (IPSS). IPSS includes irritative and obstructive symptoms. The most common drug-related side effect was retrograde ejaculation. Rates of discontinuing therapy due to retrograde ejaculation were low. The second most commonly-reported adverse event was dizziness. The incidence of treatment-related dizziness was low and only slightly higher in patients receiving silodosin compared with placebo-treated patients. SOURCE Watson Pharmaceuticals, Inc. E-mail this page to a friend or colleague! To print, use this version