Healthcare Industry News: Trelstar
News Release - April 7, 2009
Watson Announces United States Availability of RAPAFLO(TM) (silodosin), a Novel New Treatment in Benign Prostatic Hyperplasia (BPH)New product, now available in pharmacies, will provide rapid symptom relief for number one reason men visit a urologist
CORONA, Calif., April 7 (Healthcare Sales & Marketing Network) --Watson Pharmaceuticals, Inc. (NYSE: WPI ), a leading specialty pharmaceutical company, announced today that RAPAFLO(TM) (silodosin), the company's new, uniquely selective alpha blocker for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH), is available for patients by prescription. Watson received U.S. Food and Drug Administration (FDA) approval for RAPAFLO(TM) in October 2008.
In clinical trials, RAPAFLO(TM) was proven to rapidly increase urine flow in just two to six hours following the initial dose. In addition, noticeable relief of BPH symptoms was realized in just three to four days, with the majority of patients, including men on concomitant cardiovascular medications, achieving at least a three-point improvement in IPSS score, regardless of age or severity of symptoms. RAPAFLO(TM) is associated with a low incidence of orthostatic hypotension and the associated symptoms of syncope, fainting and dizziness.
"The launch of RAPAFLO(TM) is an important milestone and, coupled with the forthcoming launch of GELNIQUE, marks the continued strength and expansion of Watson's Brand Division and urology franchise," said Paul Bisaro, President and Chief Executive Officer of Watson. "We are confident that the proven rapid efficacy and safety of RAPAFLO(TM) will provide BPH patients and their physicians an important treatment option. We expect our 3-day sample packs to clearly demonstrate the rapid relief and tolerability of RAPAFLO(TM)."
The product label provides that one 8 mg RAPAFLO(TM) capsule be taken once daily with a meal. Stocking efforts have ensured the product will be available immediately by prescription at retail pharmacies nationwide.
In addition to RAPAFLO(TM), Watson will soon launch GELNIQUE, the first and only topical gel for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. Watson also has submitted a New Drug Application for a 6-month formulation of Trelstar® (triptorelin pamoate), a luteinizing hormone releasing hormone (LHRH) agonist for the palliative treatment of advanced prostate cancer. Watson anticipates that FDA will take action on this application in the third quarter 2009.
RAPAFLO(TM) is an effective, selective alpha-1 adrenergic receptor antagonist that binds with high affinity to the alpha 1a receptors concentrated in the prostate, bladder base and neck and seminal vesicles. It regulates the receptors, causing smooth muscles in these tissues to relax, resulting in improved urine flow and a reduction in BPH symptoms. The binding affinity for the alpha 1B receptors that regulate smooth muscle relaxation and blood pressure effects is lower, minimizing the potential for side effects.
In two Phase 3 studies, 8 mg once-daily RAPAFLO(TM) taken for 12 weeks resulted in significant and rapid relief of BPH symptoms compared with placebo, as measured by the International Prostate Symptom Score (IPSS). IPSS includes irritative (frequency, urgency, and nocturia), and obstructive (hesitancy, incomplete emptying, intermittency, and weak stream) symptoms. RAPAFLO also has been proven to significantly improve Qmax scores (maximum urine flow rates) as early as two hours following first dose and at 12 weeks of treatment.
In clinical trials, RAPAFLO(TM) also demonstrated minimal electro cardiac effects on the cardiovascular system, without any meaningful prolongation of the QT interval. The most common drug-related side effect was retrograde ejaculation (orgasm with reduced semen), an expected effect of selective alpha blockers. Rates of discontinuing therapy due to retrograde ejaculation were low. The second most commonly-reported adverse event was dizziness. The incidence of treatment-related dizziness was low and only slightly higher among RAPAFLO(TM) than placebo-treated patients.
Previously presented data included information that in clinical trials RAPAFLO(TM) was administered with a single dose of medications for erectile dysfunction in healthy male subjects (N=24) and that there were no reported events of symptomatic orthostatis or dizziness.
RAPAFLO(TM) was originally developed by Kissei Pharmaceutical Co., Ltd. in Japan, where RAPAFLO(TM) is the BPH market leader, and licensed to Watson for the US, Canada and Mexico markets.
About Watson Pharmaceuticals, Inc.
Watson Pharmaceuticals, Inc. is a global leader in the development and distribution of pharmaceuticals with a broad portfolio of generic products and a specialized portfolio of branded pharmaceuticals focused on Urology, Gynecology and Nephrology (Medical).
In the U.S., the Watson Brand portfolio includes RAPAFLO(TM), GELNIQUE, Trelstar® LA, Trelstar® Depot, Ferrlecit®, INFeD®, and Oxytrol®. In addition, Watson markets the following brands under co-promotion agreements: AndroGel®, with Solvay Pharmaceuticals, Inc.; Tri-Luma® Cream, with Galderma Laboratories; and Femring®, with Warner Chilcott Limited. The Watson pipeline portfolio includes a number of products, including a six-month formulation of Trelstar® for the treatment of advanced prostate cancer, which is currently under review by the FDA; URACYST®, under development for cystitis; and a novel oral contraceptive.
For press releases and other company information, visit the Watson 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 impact of competitive products and pricing; market acceptance of and continued demand for Watson's products, including RAPAFLO(TM); difficulties or delays in manufacturing; the difficulty of predicting the timing or outcome of FDA or other regulatory agency approvals or actions, if any; patents and other intellectual property rights held by the Company and the ability to successfully enforce such rights against third parties; 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, 2008.
Source: Watson Pharmaceuticals
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