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Presented Data Confirm That RAPAFLO(TM) (silodosin) Provides Rapid, Highly Effective, Symptom Relief for Benign Prostatic Hyperplasia (BPH) Patients
Date:4/28/2009

both groups.

Patients who experienced retrograde ejaculation and those who did not both showed significant improvement (p<.02) compared with patients receiving placebo in IPSS and Qmax after 12 weeks of treatment. Mean improvement in IPSS was greater in men experiencing this side effect than men who did not (-7.2 versus -6.1, p=0.3856) and for Qmax (3.1 mL versus 2.4 mL, p=0.0699).

About RAPAFLO(TM)

RAPAFLO(TM) is an effective, uniquely selective alpha-1 adrenergic receptor antagonist. RAPAFLO(TM) 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 alpha (1B) receptors that cause smooth muscle in peripheral vessels is significantly lower, which may minimize orthostatic hypotension.

The most common drug-related side effect was retrograde ejaculation. The second most commonly-reported adverse event was dizziness. The incidence of treatment-related dizziness was low and only slightly higher among RAPAFLO(TM) than placebo-treated patients (11 vs. 3 patients).

Previously presented data included information that in clinical trials RAPAFLO(TM) was administered with a single dose of medications for erectile dysfunction in healthy male subjects (N=24) and that there were no reported events of symptomatic orthostatis or dizziness. RAPAFLO(TM) demonstrated no meaningful electro cardiac effects during Phase 3 trials and during thorough QTc testing as required for new chemical entities by the FDA.

RAPAFLO(TM) was originally developed by Kissei Pharmaceutical Co., Ltd. in Japan, where RAPAFLO(TM) is the BPH market leader, and licensed to Watson for the U.S., Canada and Mexico markets. '/>"/>

SOURCE Watson Pharmaceuticals, Inc.
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