-- New product, now available in pharmacies, will provide rapid symptom
relief for number one reason men visit a urologist --
CORONA, Calif., April 7 /PRNewswire-FirstCall/ --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
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
"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(R) (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
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(R) LA, TRELSTAR(R) Depot, Ferrlecit(R), INFeD(R), and Oxytrol(R). In
addition, Watson markets the following brands under co-promotion agreements:
AndroGel(R), with Solvay Pharmaceuticals, Inc.; Tri-Luma(R) Cream, with
Galderma Laboratories; and Femring(R), with Warner Chilcott Limited. The
Watson pipeline portfolio includes a number of products, including a six-month
formulation of TRELSTAR(R) for the treatment of advanced prostate cancer,
which is currently under review by the FDA; URACYST(R), 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,
SOURCE Watson Pharmaceuticals, Inc.
of Watson Pharmaceuticals, Inc.,
of Ogilvy Public Relations,
Web Site: http://www.watson.com