New Treatment for Enlarged Prostate Increases Urine Flow Within Hours

Rapaflo® available in Canada to treat one of the most common disorders in aging men

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 concerns."

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."

ABOUT BPH

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 size.

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 flow.

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 treatment.

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

Michelle MacLeod
Hill + Knowlton Strategies
416.413.4744 / [email protected]