Watson Pharmaceuticals' RAPAFLO demonstrates safety and tolerability in BPH treatment

Dec 9 2009

Watson Pharmaceuticals, Inc. (NYSE: WPI) today announced that the results of an open-label extension of two Phase 3 studies, published in the December issue of the peer-reviewed journal Urology, demonstrate long-term safety and tolerability of RAPAFLO® (silodosin) for up to 52 weeks of treatment. RAPAFLO® is an effective and uniquely selective alpha blocker for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH), the number one reason patients visit urologists.

RAPAFLO® was shown to be well tolerated and safe throughout the one year study with low incidences of dizziness and orthostatic hypotension (drop in blood pressure upon standing). In addition, there were no serious, drug-related adverse events (AEs) reported during the study. A secondary endpoint demonstrated that RAPAFLO® significantly reduced BPH symptoms, as measured by International Prostate Symptom Score (IPSS), from baseline (week 12 of treatment) through week 52 in men who switched from placebo to RAPAFLO® in the open-label phase as well as in men continuing active treatment from the Phase 3 studies.

The patients enrolled in the 9-month, open-label extension had completed one of two identical 12-week, randomized, placebo-controlled, double-blind multi-center clinical trials. A total of 661 patients who completed the trials were enrolled in the extension.

"Relief of urinary symptoms in BPH patients is, in part, mediated by alpha 1A adrenoreceptors. First-generation alpha blockers are nonselective with regard to alpha 1 adrenoreceptor subtypes and, as a result, have been associated with orthostatic hypotension," said Leonard S. Marks, MD, author of the study and professor of urology at the Geffen School of Medicine, the University of California at Los Angeles. "RAPAFLO® has a uniquely selective profile that delivers sustained BPH symptom relief to patients with an excellent cardiovascular safety profile."