FDA Approves Rapaflo
Watson Receives US FDA Approval for Rapaflo (silodosin) for the Treatment of Benign Prostatic Hyperplasia (BPH)
CORONA, Calif., October 08, 2008 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved Rapaflo (silodosin), the company's new alpha blocker for the treatment of the signs and symptoms of BPH.
BPH is the number one reason patients visit urologists and is characterized by urination problems, including decreased urine flow, more frequent urination and nocturia. The U.S. BPH market is growing and currently exceeds $2 billion annually, of which $1.7 billion is attributed to alpha blockers.
"Rapaflo's approval is the most important milestone for the Company's Brand division thus far," said Paul Bisaro, Chief Executive Officer of Watson. "Rapaflo is a novel product that provides strong efficacy and an exceptional safety profile for patients managing their BPH. Rapaflo provides an excellent long term opportunity for Watson and will be the foundation for future growth of 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 week open label study. In the two Phase 3 studies, 923 patients (mean age 64.6 years) 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 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.
"We are pleased we received approval for Rapaflo so quickly which demonstrates, among other things, the high quality of our clinical and regulatory groups," said Mr. Bisaro. "With our oxybutynin gel NDA under consideration with the FDA and plans to file our Trelstar(R) 6 month application later this year, Watson is in a unique position to introduce products within the next 12 to 18 months that treat the top three conditions in urology."
Rapaflo is an effective, selective alpha-1 adrenergic receptor antagonist. Rapaflo binds with high affinity to the alpha (1A) receptors concentrated in the prostate, causing the smooth muscles in these tissues to relax and resulting in improved urine flow and a reduction in BPH symptoms. The binding affinity for the alpha (1B) receptors that cause smooth muscle relaxation and blood pressure effects is significantly lower, thereby maximizing target organ activity for treating BPH and minimizing the potential for side effects and interactions with other therapies.
In clinical trials, Rapaflo demonstrated strong efficacy with minimal effects on the cardiovascular system, and clinical studies have shown that Rapaflo does not cause any meaningful prolongation of the QT interval. The most common drug-related side effect was retrograde ejaculation (orgasm with reduced semen), a direct reflection of the product's selective binding properties. In targeting the 1A receptors, organ-specific activity is maximized, and cardiovascular effects are minimized. 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 than placebo-treated patients.
Recently presented data demonstrate that Rapaflo can also be administrated in combination with medications for erectile dysfunction with no symptomatic effects on blood pressure or heart rate.
Rapaflo was originally developed by Kissei Pharmaceutical Co., Ltd. in Japan and licensed to Watson for the US, Canada and Mexico markets.
About Watson Pharmaceuticals, Inc.
Watson Pharmaceuticals, Inc., headquartered in Corona, CA, is a leading specialty pharmaceutical company that develops, manufactures, markets, sells and distributes generic and specialty brand 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: Rapaflo; 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: a six-month formulation of TRELSTAR(R) (triptorelin pamoate for injectable suspension), for the treatment of advanced prostate cancer; oxybutynin topical gel, for overactive bladder and Uracyst, for cystitis.
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; 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, 2007.
Posted: October 2008
- Watson Announces Silodosin NDA Accepted for Filing by FDA for theTreatment of Benign Prostatic Hyperplasia - February 12, 2008
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