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 of 2008.
Watson submitted the filing for silodosin with data from two Phase III 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. 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).
Paul Bisaro, president and CEO of Watson, said: “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.”