August 5, 2008
Urologists Should Recognize the Cardiac Safety of Prescribed Medications, Article Concludes
CORONA, Calif., Aug. 5 /PRNewswire-FirstCall/ -- A paper published in the current issue of Reviews in Urology (2008; 10(2):85-91) concludes that urologists and other physicians treating benign prostatic hyperplasia (BPH) should prescribe medications that do not affect the heart's electrical activity (heart repolarization), especially since most men with BPH are older and often take other medications that also may impact the heart.
"In the complex and fast-paced world of medicine, where patient safety is a primary concern, physicians need to be assured that they are using agents and the best possible safety profile. This is particularly important with agents that affect heart rhythm and may predispose patients to life-threatening arrhythmias that can occur without warning," said Herbert Lepor, M.D., Professor of Urology and Martin Spatz, Chairman of the Department of Urology, New York University School of Medicine, NY, and lead author of the review article.Alpha-blockers are an easy-to-use, well-tolerated class of drugs for BPH. However, some current agents may prolong the QT interval (a measure of heart repolarization on an electrocardiogram, or ECG), thereby predisposing patients to potentially life-threatening ventricular arrhythmias. In October 2005, the U.S. Food and Drug Administration (FDA) suggested that new drugs under development, particularly agents with systemic bioavailability (i.e., drug that enter the circulatory system), should undergo critical assessment of their effect on QTc interval.*
Watson's investigational alpha-blocker, silodosin, was highlighted in the review article. The FDA is currently reviewing a New Drug Application for silodosin, for the treatment of BPH. If approved, silodosin will provide an important option for men with BPH.
"Many urologists and other physicians who treat BPH don't often have access to ECG to monitor the cardiac safety of the agents they prescribe," said Norman Lepor, M.D., a cardiologist and associate clinical professor of medicine, University of California, Los Angeles (UCLA) Cedars-Sinai Medical Center, and co-author of the new review article. "Therefore, it's important that physicians recognize which agents affect the QTc interval and to avoid those agents if an alternative is available."
For a copy of Dr. Lepor's review article ("Treatment Update -- The QT Interval and Selection of Alpha-Blockers for Benign Prostatic Hyperplasia"), please contact Watson Medical Communications at (800) 272-5525.
Silodosin is a novel, uniquely selective alpha (1A)-adrenoceptor antagonist originally developed by Kissei Pharmaceutical Co., Ltd. in Japan and licensed to Watson for the U.S., Canada and Mexico. Silodosin preferentially binds to the alpha (1A) receptors in the prostate, bladder neck, urethra, and vas deferens relative to cardiovascular associated adrenoreceptors, thereby maximizing target organ activity while minimizing the potential for blood pressure effects. Urief(R) (silodosin) 4mg, dosed twice daily, was launched in Japan in May 2006 and is marketed by Kissei in cooperation with Daiichi Sankyo Co., Ltd. Silodosin is under development in the U.S. for the treatment of the signs and symptoms of BPH.
About Watson Pharmaceuticals, Inc.
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. Watson pursues a growth strategy combining internal product development, strategic alliances and collaborations and synergistic acquisitions of products and businesses.
The mission of Watson Urology is to offer products and services that improve the quality of patients' lives, and satisfy the needs of physicians who specialize in the diagnosis, management, and treatment of urological disorders. By advancing education and support for urological diseases, we are creating the differences that make life more livable.
In the U.S., the Watson urology portfolio includes: Oxytrol(R); TRELSTAR(R) LA; TRELSTAR(R) Depot; Androderm(R); ProQuin(R) XR, under a co-promotion agreement with Depomed, Inc.; and AndroGel(R), under a co-promotion agreement with Solvay Pharmaceuticals, Inc. The Watson portfolio also includes a number of products under development including: silodosin, a product under development for the treatment of benign prostatic hyperplasia; a six-month formulation of TRELSTAR(R) (triptorelin pamoate for injectable suspension), under development for the treatment of advanced prostate cancer; and oxybutynin topical gel, under development for overactive bladder.
For press releases and other company information, visit Watson Pharmaceuticals' Web site at http://www.watson.com/.
Any statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Watson's current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Watson disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Watson's current expectations depending upon a number of factors affecting Watson's business. These factors include, among others, the difficulty of predicting the timing or outcome of product development efforts and FDA or other regulatory agency approvals or actions, if any; whether the results of clinical trials for silodosin and other information will be sufficient to support approval by FDA or other regulatory authorities; impact of competitive products and pricing; market acceptance of and continued demand for Watson's products; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Watson's periodic public filings with the Securities and Exchange Commission, including but not limited to Watson's Annual Report on Form 10-K for the year ended December 31, 2007.
* US FDA. Guidance for Industry E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs. October 2005. Available at: http://www.fda.gov/cber/gdlins/iche14qtc.htm#v (Logo: http://www.newscom.com/cgi-bin/prnh/20020214/WATSONLOGO)
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Watson Pharmaceuticals, Inc.
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