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Feds Approve Drug for Enlarged Prostate

Once-daily pill said to relieve common problem in older men

October 13, 2008

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The U.S. Food and Drug Administration has approved silodosin capsules, which are sold under the brand name Rapaflo, for the treatment of symptoms due to benign prostatic hyperplasia (BPH), a condition also known as an enlarged prostate.

BPH is a male disease wherein the prostate gland -- located between the bladder, which stores urine, and the urethra, the tube through which urine exits the body -- enlarges in men as they age. By age 50, roughly 50 percent of all men suffer from BPH. By age 80, that number jumps to 75 percent.

"Benign prostatic hyperplasia can seriously impact the quality of life of men as they age," said George Benson, deputy director, Division of Reproductive and Urological Products, FDA. "This product will provide another treatment option for men suffering symptoms of an enlarged prostate."

As men age, their prostate gland enlarges and begins to press against their urethra. This pressure can impede the flow of urine and make it difficult to eliminate it from the body.

In the early stages of BPH, the disease can also create a need to urinate more frequently, or cause dribbling after urination.

BPH can also lead to an increased risk of urinary tract infections and urinary retention. Urinary retention can damage the kidneys and cause urinary tract infections by mixing urine from the ureter with urine from the bladder that is heavily burdened with bacteria.

Rapaflo works by blocking the alpha-1 adrenoreceptors in the prostate, bladder, and urethra. By blocking these receptors, this treatment allows the smooth muscle in these tissues to relax, resulting in a reduction in BPH symptoms.

Rapaflo will be available in a once-daily capsule. An 8-milligram (mg) daily dose is recommended for men who do not suffer from kidney or liver impairment.

A 4 mg daily dose will be available for men with moderate kidney (renal) impairment. Rapaflo is not recommended for men with severe kidney (renal) or liver (hepatic) impairment and is not approved for pediatric use.

It is important that patients know and health care professionals recognize that cancer of the prostate gland and BPH cause many of the same symptoms and that these two diseases, BPH and prostate cancer, frequently co-exist.

Therefore, patients thought to have BPH should be examined prior to starting therapy with Rapaflo to rule out the presence of prostate cancer.

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