Rapaflo (silodosin), an alpha blocker marketed by Watson Pharmaceuticals, Inc., in Corona, Calif., for oral, once-daily treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) has received approval.
In two phase 3 trials, a daily 8-mg dose of Rapaflo for 12 weeks resulted in significant, rapid relief of BPH symptoms, compared with placebo, as measured by the International Prostate Symptom Score (IPSS).
The drug also has been shown to significantly improve maximum urine flow rates as soon as two hours following the first dose.
“Rapaflo is a novel product that provides strong efficacy and an exceptional safety profile for patients managing their BPH,” said Paul Bisaro, chief executive officer of Watson. The company expects to launch Rapaflo in early 2009.