Rapaflo silodosin: Phase II data

A double-blind Phase II trial in 151 patients with moderate to severe non-bacterial CP/CPPS showed that once-daily 4 mg Rapaflo met the primary endpoint of significantly reducing NIH-CPSI total score from baseline to week 12 vs. placebo (12.1 vs. 8.5 points, p=0.0224). On secondary endpoints, Rapaflo significantly reduced NIH-CPSI urinary symptom score (2.2 vs. 1.3 points, p=0.0102) and improved SF-12 physical component score vs. placebo (4.2 vs. 1.7 points, p=0.049). Additionally, a significantly greater proportion of patients treated with Rapaflo reported "moderate" or "marked" improvement in global response assessment vs. placebo (56% vs. 29%, p=0.0069). Watson said an increase in dose to 8 mg resulted in no incremental increased effect. Data were presented at the American Urological Association meeting in Washington. ...