Watson Announces United States Availability of RAPAFLO(TM) (silodosin), a Novel New Treatment in Benign Prostatic Hyperpl...(will be available immediately by prescri...),Health

In addition to RAPAFLO(TM), Watson will soon launch GELNIQUE, the first and only topical gel for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. Watson also has submitted a New Drug Application for a 6-month formulation of Trelstar(R) (triptorelin pamoate), a luteinizing hormone releasing hormone (LHRH) agonist for the palliative treatment of advanced prostate cancer. Watson anticipates that FDA will take action on this application in the third quarter 2009.

About RAPAFLO

RAPAFLO(TM) is an effective, selective alpha-1 adrenergic receptor antagonist that binds with high affinity to the alpha 1a receptors concentrated in the prostate, bladder base and neck and seminal vesicles. It regulates the receptors, causing smooth muscles in these tissues to relax, resulting in improved urine flow and a reduction in BPH symptoms. The binding affinity for the alpha 1B receptors that regulate smooth muscle relaxation and blood pressure effects is lower, minimizing the potential for side effects.

In two Phase 3 studies, 8 mg once-daily RAPAFLO(TM) taken for 12 weeks resulted in significant and rapid relief of BPH symptoms compared with placebo, as measured by the International Prostate Symptom Score (IPSS). IPSS includes irritative (frequency, urgency, and nocturia), and obstructive (hesitancy, incomplete emptying, intermittency, and weak stream) symptoms. RAPAFLO 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.

In clinical trials, RAPAFLO(TM) also demonstrated minimal electro cardiac effects on the cardiovascular system, without any meaningful prolongation of the QT interval. The most common drug-related side effect was retrograde ejaculation
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