Watson Receives US FDA Approval for RAPAFLO(TM) (silodosin) for the Treatment of Benign Prostatic Hyperplasia (BPH)
BPH is the number one reason patients visit urologists and ischaracterized by urination problems, including decreased urine flow, morefrequent urination and nocturia. The U.S. BPH market is growing and currentlyexceeds $2 billion annually, of which $1.7 billion is attributed to alphablockers.
"RAPAFLO's approval is the most important milestone for the Company'sBrand division thus far," said Paul Bisaro, Chief Executive Officer of Watson."RAPAFLO is a novel product that provides strong efficacy and an exceptionalsafety profile for patients managing their BPH. RAPAFLO provides an excellentlong term opportunity for Watson and will be the foundation for future growthof our urology franchise."
Today's approval is based on data from two Phase 3, 12-week, randomized,double-blind, placebo-controlled, multi-center studies as well as a 40 weekopen label study. In the two Phase 3 studies, 923 patients (mean age 64.6years) were randomized to receive either RAPAFLO 8 mg once-daily or placebo.In the two trials, 8 mg once-daily RAPAFLO for 12 weeks resulted insignificant and rapid relief of BPH symptoms, compared with placebo, asmeasured by the International Prostate Symptom Score (IPSS). IPSS includesirritative (frequency, urgency, and nocturia), and obstructive (hesitancy,incomplete emptying, intermittency, and weak stream) symptoms. RAPAFLO alsohas been proven to significantly improve Qmax scores (maximum urine flowrates) as early as two hours following first dose and at 12 weeks oftreatment.
"We are pleased we received approval for RAPAFLO so quickly whichdemonstrates, among other things, the high quality of our clinical andregulatory groups," said Mr. Bisaro. "With our oxybutynin gel NDA underconsideration with the FDA and plans to file our Trelstar(R) 6 monthapplication later this year, Watson is in a unique position to introduceproducts within the next 12 to 18 months that treat the top three conditionsin urology."
RAPAFLO is an effective, selective alpha-1 adrenergic receptor antagonist.RAPAFLO binds with high affinity to the alpha (1A) receptors concentrated inthe prostate, causing the smooth muscles in these tissues to relax andresulting in improved urine flow and a reduction in BPH symptoms. The bindingaffinity for the alpha (1B) receptors that cause smooth muscle relaxation andblood pressure effects is significantly lower, thereby maximizing target organactivity for treating BPH and minimizing the potential for side effects andinteractions with other therapies.
In clinical trials, RAPAFLO demonstrated strong efficacy with minimaleffects on the cardiovascular system, and clinical studies have shown thatRAPAFLO does not cause any meaningful prolongation of the QT interval. Themost common drug-related side effect was retrograde ejaculation (orgasm withreduced semen), a direct reflection of the product's selective bindingproperties. In targeting the 1A receptors, organ-specific activity ismaximized, and cardiovascular effects are minimized. Rates of discontinuingtherapy due to retrograde ejaculation were low. The second mostcommonly-reported adverse event was dizziness. The incidence oftreatment-related dizziness was low and only slightly higher among RAPAFLOthan placebo-treated patients.
Recently presented data demonstrate that RAPAFLO can also be administratedin combination with medications for erectile dysfunction with no symptomaticeffects on blood pressure or heart rate.
RAPAFLO was originally developed by Kissei Pharmaceutical Co., Ltd. inJapan and licensed to Watson for the US, Canada and Mexico markets.
About Watson Pharmaceuticals, Inc.
Watson Pharmaceuticals, Inc., headquartered in Corona, CA, is a leadingspecialty pharmaceutical company that develops, manufactures, markets, sellsand distributes generic and specialty brand pharmaceutical products. Watsonpursues a growth strategy combining internal product development, strategicalliances and collaborations and synergistic acquisitions of products andbusinesses.
The mission of Watson Urology is to offer products and services thatimprove the quality of patients' lives, and satisfy the needs of physicianswho specialize in the diagnosis, management, and treatment of urologicaldisorders. By advancing education and support for urological diseases, we arecreating the differences that make life more livable.
In the U.S., the Watson Urology portfolio includes: RAPAFLO(TM);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 aco-promotion agreement with Solvay Pharmaceuticals, Inc. The Watson portfolioalso includes a number of products under development including: a six-monthformulation of TRELSTAR(R) (triptorelin pamoate for injectable suspension),for the treatment of advanced prostate cancer; oxybutynin topical gel, foroveractive bladder and Uracyst(TM), for cystitis.
For press releases and other company information, visit WatsonPharmaceuticals' Web site at http://www.watson.com.
Any statements contained in this press release that refer to future eventsor other non-historical facts are forward-looking statements that reflectWatson's current perspective of existing trends and information as of the dateof this release. Except as expressly required by law, Watson disclaims anyintent or obligation to update these forward-looking statements. Actualresults may differ materially from Watson's current expectations dependingupon a number of factors affecting Watson's business. These factors include,among others, the impact of competitive products and pricing; marketacceptance of and continued demand for Watson's products, including RAPAFLO;difficulties or delays in manufacturing; the difficulty of predicting thetiming or outcome of FDA or other regulatory agency approvals or actions, ifany; patents and other intellectual property rights held by the Company andthe ability to successfully enforce such rights against third parties; andother risks and uncertainties detailed in Watson's periodic public filingswith the Securities and Exchange Commission, including but not limited toWatson's Annual Report on Form 10-K for the year ended December 31, 2007.
SOURCE Watson Pharmaceuticals, Inc.
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