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RAPAFLO(TM) (silodosin) Provides Rapid and Sustained Benign Prostatic Hyperplasia (BPH) Symptom Relief in as Little as Three Days
Date:5/8/2009

older with signs and symptoms of BPH, including a peak urine flow rate (Qmax) between 4 and 15 mL/sec (mean of 8.7 to 8.9) and International Prostate Symptom Score (IPSS) greater than or equal to 13 (mean of 21.3). IPSS includes irritative (frequency, urgency, and nocturia), and obstructive (hesitancy, incomplete emptying, intermittency, and weak stream) symptoms. Patients were randomized to either 8 mg RAPAFLO(TM) (n=466) or placebo (n=457) taken once daily with breakfast for 12 weeks.

The primary endpoint was change in IPSS from baseline to the last observation, including sub-scores related to irritative symptoms and obstructive symptoms. Change in peak urinary flow rate (Qmax scores) was a secondary endpoint.

At the last observation, patients treated with RAPAFLO(TM) versus placebo experienced significantly greater changes in total IPSS from baseline measures (-6.4 vs. -3.5, respectively; p<0.0001), as well as irritative (-2.3 vs. -1.4, respectively; p<0.0001) and obstructive (-4.0 vs. -2.1, respectively; p<0.0001) sub-scores. These differences were significantly better for RAPAFLO(TM) vs. placebo after three to four days of treatment (p<0.0001 for total IPSS and obstructive sub-score; p=0.0002 for irritative sub-score). RAPAFLO(TM) also significantly improved Qmax scores as early as two to six hours after the first dose and was sustained through 12 weeks of treatment.

The most common drug-related adverse event (AE) was retrograde ejaculation (orgasm with reduced semen), an expected treatment effect of selective alpha blockers, which occurred in 28 percent of men treated with RAPAFLO(TM). Retrograde ejaculation, a reversible treatment effect, led to treatment discontinuation in only 2.8 percent of patients, and does not pose a safety concern. Incidences of orthostatic hypotension among RAPAFLO(TM)- and placebo-treated patients were similar and low (2.6%
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SOURCE Watson Pharmaceuticals, Inc.
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