Watson Announces Silodosin NDA Accepted for Filing by FDA for the Treatment of Benign Prostatic H...( CORONA Calif. Feb. 12 /- WatsonPh...),Health

CORONA, Calif., Feb. 12 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI), a leading specialty pharmaceutical company, today announced that its New Drug Application (NDA) for silodosin, a novel alpha(1)- adrenoreceptor antagonist, has been accepted for filing by the U.S. Food and Drug Administration (FDA). Watson is seeking marketing approval of silodosin from the FDA for the treatment of the signs and symptoms associated with benign prostatic hyperplasia (BPH), or enlarged prostate. Watson anticipates that the FDA will take action on its application in the fourth quarter 2008.

Silodosin was designed to decrease urinary resistance and improve dysuria (difficulty or pain in urination) associated with BPH. In clinical trials, silodosin demonstrated a very low level of the most highly-reported cardiovascular and blood pressure-related side effects associated with existing BPH treatments, including dizziness and first-dose syncope (fainting).

"This filing highlights Watson's capabilities in new drug development and our commitment to this product, providing solutions to the millions of men with BPH symptoms," said Paul Bisaro, Watson's President and Chief Executive Officer. "Watson is expanding the portfolio it offers to urologists and their patients, focusing on symptom management that makes a big difference in their day-to-day lives."

Watson submitted the filing for silodosin with data from two Phase 3 multi-center (88 sites), randomized, double-blind, placebo-controlled trials that evaluated a total of 923 patients with signs and symptoms of BPH for 12 weeks. The trials demonstrated that a once daily 8mg dose of silodosin given for 12 weeks provided significant relief of BPH symptoms, compared with place
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