Rapaflo® available in Canada to treat one of the most common disorders in aging
OAKVILLE, ON, Sept. 25, 2012 /CNW/ - Watson Pharma Company today
announced that Rapalfo® (silodosin), a new treatment for benign
prostatic hyperplasia (BPH), is available in Canada. BPH is a common,
non-cancerous enlargement of the prostate associated with urinary
problems, including decreased urine flow and poor bladder emptying. The condition affects 40 to 60 per cent of men over age 60, and more
than 80 per cent of men over age 80. BPH can cause serious medical
complications and a significant reduction in quality of life.
"BPH is a troublesome condition associated with urinary frequency,
urgency, leakage, a weak stream, and the frustrating sensation of not
being able to completely empty the bladder," says Dr. Paul Whelan,
Braley-Gordan Chair and Professor of Urology at McMaster University.
"This leads to increased trips to the bathroom, especially at night,
resulting in sleep disturbances, fatigue, and overall reduced vitality.
It can also lead to chronic urinary retention and other serious health
Rapaflo is indicated for the treatment of the signs and symptoms of
BPH. It provides rapid improvement of BPH symptoms, including
increased urine flow within two to six hours, and an overall
improvement in BPH symptoms over one year of treatment. Rapaflo has few
side effects because of its high selectivity to the prostate. Treatment
with Rapaflo for up to 52 weeks resulted in no significant effect on
libido or prostate-specific antigen (PSA).
"Rapaflo is an important new treatment option," says Dr. Whelan. "Some
of my patients were making five or six trips to the bathroom during the
night. Now they're sleeping, and telling me that they feel so much
better the next day because of it. This contributes significantly to
their overall health and well-being."
BPH is an irregular enlargement of the prostate. Because the prostate
surrounds the urethra (the passageway though which urine empties from
the bladder), enlargement of the prostate may constrict the urethra and
interfere with urination. An enlarged prostate may also cause the
muscular bladder wall to thicken, reducing the bladder's ability to
store urine. This may result in frequent need for urination and sudden
strong urges to urinate.
BPH is one of the most common disorders in aging men, and its prevalence
continues to increase as the population ages. Although prostate
enlargement is common in association with the signs and symptoms of
BPH, the severity of BPH-related symptoms is not correlated to prostate
There is no evidence that BPH leads to prostate cancer; however,
symptoms of both disorders are similar, and it is possible to have both
BPH and prostate cancer at the same time. BPH can cause chronic
urinary retention, which in turn can lead to bladder infections,
bladder stones, urinary tract infections, renal impairment and renal
failure. Many men with BPH also suffer from declining sexual function.
ABOUT RAPAFLO™ (SILODOSIN)
Rapaflo is a selective alpha-1 adrenergic (α 1A) blocker that binds with high affinity to the alpha 1a receptors
concentrated in the prostate and bladder. It regulates the receptors,
causing smooth muscles in these tissues to relax, resulting in improved
urine flow and a reduction in BPH symptoms.
In two Phase 3 studies, Rapaflo 8 mg once-daily 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). The IPSS includes irritative symptoms (frequency, urgency, and
nocturia), and obstructive symptoms (hesitancy, incomplete emptying,
intermittency, and weak stream) symptoms. Rapaflo also has been proven
to significantly improve urine flow rates (as measured by the Qmax
Scores) as early as two hours following first dose. Rapaflo is the only
alpha blocker to have demonstrated such quick improvements in urine
In clinical trials, Rapaflo demonstrated excellent safety and
tolerability with few interactions and cardiovascular side effects, and
very low rate of headaches, dizziness, fatigue or malaise (asthenia).
The most common drug-related side effect was retrograde ejaculation
(orgasm with reduced semen), an expected effect of selective alpha
blockers. For those patients who experienced retrograde ejaculation,
their ejaculation returned to normal upon discontinuation of the
ABOUT WATSON PHARMA COMPANY
Watson Pharma Company is the newly-formed Canadian subsidiary of Watson
Pharmaceuticals, Inc. Established in 2011 and headquartered in
Oakville, Ontario, it is engaged in the marketing, sale and
distribution of branded pharmaceutical products to the Canadian market.
Watson is focused on delivering innovative products that address key
therapeutic categories in Urology and Women's Health. As a subsidiary
of Watson Pharmaceuticals, it is supported by Watson's sophisticated
R&D and manufacturing capabilities, and one of the industry's leading
global supply chains. For press release and other company information,
visit Watson Pharma Company's website at www.WatsonPharmaCompany.ca
SOURCE: Watson Pharma Company
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