Watson
Pharmaceuticals, Inc. (NYSE: WPI), a leading specialty pharmaceutical
company, announced that investigators presented efficacy and safety
data on silodosin, its investigational treatment for benign prostatic
hyperplasia (BPH, or prostate enlargement), at two regional meetings of the
American Urological Association (AUA). The trade name for silodosin will be
RAPAFLO(TM).
These abstracts included results of Phase 3 studies, which showed that
treatment with RAPAFLO for up to one year effectively reduces the symptoms
of BPH and is well tolerated without causing any significant changes in
blood pressure or adverse cardiac effects. Cardiac safety data further
demonstrated that RAPAFLO, used alone or in combination with medications
for erectile dysfunction (ED), showed only minimal effects on blood
pressure or heart rate.
"We are excited by these clinical data as they further support the
strong and sustained efficacy, as well as the safety and tolerability of
RAPAFLO that have been demonstrated in other trials," said Edward Heimers,
Jr., Executive Vice President and President of Watson's Brand Division. "As
a highly selective alpha-1A blocker, we believe that RAPAFLO will address
an important medical need in urology. Earlier this year, the New Drug
Application for RAPAFLO was filed, and we look forward to working with the
U.S., Food and Drug Administration to make this treatment option available
to patients."
Data at the New England Regional AUA
At this year's New England Regional meeting of the AUA, investigators
presented two abstracts on the efficacy and safety of RAPAFLO.
The first abstract was a pooled analysis of two Phase 3 double-blind,
placebo-controlled trials involving 923 generally healthy men ages 50 or
older, with signs and symptoms of BPH, including a peak urine flow rate
(Qmax) between 4 and 15 mL/sec (mean of 8.7 to 8.9) and International
Prostate Symptom Score (IPSS) > or = 13 (mean of 21.3). Patients were
randomized to either 8 mg RAPAFLO once daily (n=466) or placebo (n=457) for
12 weeks.
After 12 weeks of treatment, RAPAFLO significantly improved urinary
symptoms, including IPSS (the primary endpoint), compared to placebo (mean
reduction of -6.4 vs. -3.5, respectively; p
Over the course of 12 weeks, treatment was well tolerated and the
effect on blood pressure was similar between the RAPAFLO and placebo
groups. Incidences of treatment-related dizziness and headache were low.
Adverse events were minimal and were generally mild and related to
retrograde ejaculation (reduced semen). There were no treatment-related
cardiac events or hypertension.
The second abstract included data from a 9-month, open-label extension
trial involving patients who had successfully completed the two previous
12-week, Phase 3 trials. A total of 661 patients were enrolled to receive
RAPAFLO 8 mg once daily for an additional 40 weeks; 435 (65.8%) completed
the extension study. A safety evaluation was based on adverse events, vital
signs and clinical laboratory tests, electrocardiography (ECG), and
physical examinations. An efficacy endpoint was change in IPSS at 40 weeks.
All 661 patients were included in the safety evaluation. Over the
course of one-year of treatment, RAPAFLO was shown to be safe and well
tolerated. Sixty-five percent (65.2%) of all patients reported at least one
adverse event; less than one third of these (28.4%) were drug related.
There were no serious drug-related adverse events. RAPAFLO was not
associated with any clinically meaningful changes in blood pressure,
clinical laboratory parameters, ECG results, or physical examination
findings. Retrograde ejaculation (reduced semen) was the most common
adverse event, though it rarely leads to drug discontinuation.
In the evaluable population of 429 (64.9%) patients, the IPSS decreased
by a mean of 3.1 points between weeks 0 and 40. Although the change was
larger (mean .4.4 points) in patients previously given placebo, the total
score also decreased (mean .1.6 points) in patients previously treated with
RAPAFLO. Treatment with RAPAFLO for up to one year also reduced IPSS
irritative subscore (-1.7 points in patients previously on placebo and -0.6
in patients continuing RAPAFLO) and obstructive subscore (-2.7 in patients
previously on placebo and -1.0 in patients continuing RAPAFLO).
Data at the Mid Atlantic Regional AUA
A placebo-controlled, open-label, crossover trial, presented at the Mid
Atlantic Regional meeting, evaluated the concomitant use of RAPAFLO with
the maximum doses of sildenafil or tadalafil, two agents commonly used to
treat ED.
In the study, 22 healthy men (ages 45 to 78 years) received 8 mg
RAPAFLO once daily for 21 days. On days 7, 14, and 21, subjects randomly
received a single dose of 100 mg sildenafil, 20 mg tadalafil, or placebo.
Resting (baseline) and standing orthostatic measurements were performed 0h
(predose) to 12h after single-dose treatment. A positive orthostatic test
was defined as a decrease in systolic (or diastolic) blood pressure by >30
(or >20) mm Hg, increased heart rate (>20 bpm), or orthostatic symptoms on
change of position, such as dizziness.
Overall, concomitant use of RAPAFLO and maximum doses of sildenafil or
tadalafil in healthy men caused no symptomatic changes in blood pressure,
heart rate, or orthostatic symptoms. The cumulative number of positive
orthostatic tests was similar for all treatments -- in 16 subjects or
= 65 years (sildenafil, 6; tadalafil, 8; placebo 5).
"These data provide important new evidence about this potential
treatment option for BPH. Considering that many men with BPH also have
other co-morbid conditions, including erectile dysfunction, heart failure,
hypertension and coronary artery disease, it's important to find
complementary treatments that can be used with other medications without
deleterious cardiovascular interactions, including the prolongation of the
QTc interval and do not complicate patient care," said Norman Lepor, M.D.,
a cardiologist and associate clinical professor of medicine, University of
California, Los Angeles (UCLA) and attending cardiologist at the Heart
Institute at Cedars-Sinai Medical Center.
About RAPAFLO(TM) (silodosin)
RAPAFLO is a highly selective alpha-1 adrenergic receptor antagonist
under development in the US for the treatment of the signs and symptoms of
benign prostatic hyperplasia (BPH). RAPAFLO binds with high affinity to the
alpha (1A) receptors in the prostate causing the smooth muscles in these
tissues to relax, resulting in an improvement in 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 in the
cardiovascular system is significantly lower, thereby maximizing target
organ activity for treating BPH while minimizing the potential for blood
pressure effects. 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 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 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 OTG, under development for overactive bladder.
For press releases and other company information, visit Watson
Pharmaceuticals' Web site at http://www.watson.com.
Forward Looking Statement
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; the impact of
competitive products and pricing; market acceptance of and continued demand
for Watson's products, including silodosin; 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.
Watson Pharmaceuticals, Inc.
http://www.watsonpharm.com
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