The double-blind, 12-week, placebo-controlled Phase 2 study evaluated the safety and efficacy of RAPAFLO(R) in patients with moderate to severe non-bacterial CP/CPPS who previously had not received alpha-blockers for the condition. Patients with National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) total score >/=15 (moderate to severe), NIH-CPSI pain score >/=8 (mild to moderate), and pelvic pain for >/=3 months before screening were randomized to RAPAFLO(R) 4 mg or 8 mg per day, or placebo. The primary measure of efficacy was improvement in the NIH-CPSI total score. Of 151 participants, 76.2 percent completed the study. The median age of patients was 48.2 years; 80.1 percent had experienced pain for at least one year.
Secondary end points evaluated were: safety; change from baseline in NIH-CPSI pain, urinary, and quality of life scores; and change from baseline in Medical Outcomes Study Short Form 12 (SF-12) physical and mental component scores. Additional secondary end points were percentages of participants who had a sufficiently significant decrease in total score (NIH-CPSI responders) and of those who indicated "markedly improved" or "moderately improved" on the global response assessment (GRA) scale (GRA responders).
About RAPAFLO(R) (silodosin)
RAPAFLO(R) was first approved by the FDA two years ago for the treatment of signs and symptoms of benign prostatic hyperplasia (BPH). RAPAFLO(R) is an effective, uniquely selective alpha-1 adrenergic receptor antagonist. RAPAFLO(R) maximizes target organ activity by binding with high affinity to the alpha (1A) receptors concentrated in the prostate. The antagonism of these receptors cause the smooth muscles in these tissues to relax and results in improved urine flow and a reduction in BPH symptoms. The binding affinity for the alp
|SOURCE Watson Pharmaceuticals, Inc.|
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