Watson Pharmaceuticals, Inc, a leading specialty pharmaceutical company, announced that investigators presented efficacy and safety data on silodosin, its investigational treatment for benign prostatic hyperplasia (BPH, or prostate enlargement), at two regional meetings of the American Urological Association (AUA). The trade name for silodosin will be Rapaflo.
These abstracts included results of phase-3 studies, which showed that treatment with Rapaflo for up to one year effectively reduces the symptoms of BPH and is well tolerated without causing any significant changes in blood pressure or adverse cardiac effects. Cardiac safety data further demonstrated that Rapaflo, used alone or in combination with medications for erectile dysfunction (ED), showed only minimal effects on blood pressure or heart rate.
"We are excited by these clinical data as they further support the strong and sustained efficacy, as well as the safety and tolerability of Rapaflo that have been demonstrated in other trials," said Edward Heimers, junior executive vice president and president of Watson's Brand Division. "As a highly selective alpha-1A blocker, we believe that Rapaflo will address an important medical need in urology. Earlier this year, the New Drug Application for Rapaflo was filed, and we look forward to working with the US, Food and Drug Administration to make this treatment option available to patients."
Rapaflo is a highly selective alpha-1 adrenergic receptor antagonist under development in the US for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).
Watson Pharmaceuticals, Inc., headquartered in Corona, CA, is a leading specialty pharmaceutical company that develops, manufactures, markets, sells and distributes brand and generic pharmaceutical products.