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news.RAPAFLO (silodosin) reduced symptoms of moderate to severe chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) in men and also improved urinary symptoms as well as quality of life, according to a Phase 2 study by Watson Pharmaceuticals.
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RAPAFLO, a selective alpha-1 adrenergic receptor antagonist, maximizes target organ activity by binding with high affinity to the alpha (1A) receptors concentrated in the prostate.
The double-blind, 12-week, placebo-controlled Phase 2 study evaluated the safety and efficacy of RAPAFLO in patients with moderate to severe non-bacterial CP/CPPS who previously had not received alpha-blockers for the condition.
The primary measure of efficacy was improvement in the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) total score.
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.
Kingston General Hospital urologist, Queen’s University in Kingston, Ontario, Canada Urology professor and lead author of the study J Curtis Nickel said RAPAFLO has demonstrated significantly improved outcomes in men suffering from CP/CPPS.
"Importantly, twice as many men treated with RAPAFLO 4 mg once daily versus placebo reported feeling a moderate to marked improvement in their condition, showing that the statistically significant findings also were clinically meaningful for the patients, Nickel said.
Originally developed by Kissei Pharmaceutical in Japan, RAPAFLO is licensed to Watson for the US, Canada and Mexico markets.