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Watson Receives US FDA Approval for RAPAFLO(TM) (silodosin) for the Treatment of Benign Prostatic Hyperplasia (BPH)
Date:10/8/2008

PAFLO also has been proven to significantly improve Qmax scores (maximum urine flow rates) as early as two hours following first dose and at 12 weeks of treatment.

"We are pleased we received approval for RAPAFLO so quickly which demonstrates, among other things, the high quality of our clinical and regulatory groups," said Mr. Bisaro. "With our oxybutynin gel NDA under consideration with the FDA and plans to file our Trelstar(R) 6 month application later this year, Watson is in a unique position to introduce products within the next 12 to 18 months that treat the top three conditions in urology."

About RAPAFLO

RAPAFLO is an effective, selective alpha-1 adrenergic receptor antagonist. RAPAFLO binds with high affinity to the alpha (1A) receptors concentrated in the prostate, causing the smooth muscles in these tissues to relax and resulting in improved urine flow and a reduction in BPH symptoms. The binding affinity for the alpha (1B) receptors that cause smooth muscle relaxation and blood pressure effects is significantly lower, thereby maximizing target organ activity for treating BPH and minimizing the potential for side effects and interactions with other therapies.

In clinical trials, RAPAFLO demonstrated strong efficacy with minimal effects on the cardiovascular system, and clinical studies have shown that RAPAFLO does not cause any meaningful prolongation of the QT interval. The most common drug-related side effect was retrograde ejaculation (orgasm with reduced semen), a direct reflection of the product's selective binding properties. In targeting the 1A receptors, organ-specific activity is maximized, and cardiovascular effects are minimized. Rates of discontinuing therapy due to retrograde ejaculation were low. The second most commonly-reported adverse event was dizziness. The incidence of treatment-related dizziness was low and only slightly higher among RAPAFLO than placebo-treated patients.

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SOURCE Watson Pharmaceuticals, Inc.
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