Watson Announces Positive Data for Its New Investigational Products for Benign Prostatic Hyperplasia and Overacti...(pment of cardiac arrhythmias which can l...),Health

Date:5/21/2008

pment of cardiac arrhythmias, which can lead to sudden death. The investigators concluded that silodosin did not demonstrate any meaningful effect on heart rate or QTc interval duration. The most common side effects seen greater than 2% were retrograde ejaculation (reduced semen) and dizziness. The abstract (Double-blind, Randomized, Parallel-Group Study to Define Electrocardiographic Effects of Silodosin, a Uroselective alpha-Adrenergic Antagonist) was presented by Herbert Lepor, M.D., Department of Urology, New York University School of Medicine, NY, on Wednesday, May 21 at 2:10 pm.

"The effects of silodosin on the QTc interval were rigorously evaluated," said Dr. Lepor. "Our results found that silodosin does not affect the QT interval. QTc prolongation has been observed with other alpha blockers. Therefore, this is an important study for the development of any alpha blocker."

The second trial (abstract #1508) found that OTG produces serum levels similar to an already-approved oxybutynin transdermal patch (Oxytrol(R)), but demonstrates improved skin tolerability that may lead to greater patient acceptability and use. As expected, dry mouth and application site dermatitis were the only treatment-related side effects reported in more than 2% of participants. OTG is designed to provide the same advantages as the patch over a pill formulation, in terms of convenience, ease of delivery, and a lower risk of anticholinergic side effects such as dry mouth and constipation. The abstract (Steady-State Pharmacokinetics of an Investigational Oxybutynin Topical Gel in Comparison with Oxybutynin Transdermal System) was presented by David R. Staskin, M.D., Department of Urology, Weill Medical College of Cornell University, NY, on Tuesday, May 20 at 2:30 pm.

"I would expect that based on the comparative serum levels of oxybutynin and desethyloxybutynin, the gel formulation will preserve many of the advantages associated with the transdermal patch with the pot
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SOURCE Watson Pharmaceuticals, Inc. Copyright©2008 PR Newswire. All rights reserved

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