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FDA APPROVES PROSTATE DRUG

 FDA APPROVES PROSTATE DRUG
 WASHINGTON, June 22 /PRNewswire/ -- The Food and Drug


Administration today announced the approval of finasteride, the first drug to treat benign prostatic hyperplasia (BPH), a common problem in older men caused by enlargement of the prostate gland.
 The only other treatment for BPH has been surgery and other mechanical procedures to reduce prostate size.
 BPH is a slowly progressive chronic condition. The problem is common in older men. The prostate, a walnut-sized gland located at the base of the bladder encircling the urethra that contributes enzymes and acids to semen, enlarges gradually and may eventually block the urethra and obstruct the outflow of urine. Prolonged obstruction can damage the kidneys. The cause of BPH is unknown, but some doctors believe that it may be a reaction to alterations in hormonal balance associated with aging.
 In controlled clinical trials of the drug involving 1,645 patients, participants received either a placebo, 1 milligram of finasteride, or 5 milligrams of finasteride. The studies demonstrated that finasteride decreased the prostate size by about 20 percent in patients treated for 12 months, and that about 50 percent of patients experienced an increase in urine flow and improvement in symptoms.
 "This approval represents a significant improvement in therapy alternatives for a common condition in older men," said FDA Commissioner David A. Kessler, M.D. "This is particularly significant for the growing elderly population in the United States."
 The most common adverse effects reported with finasteride are decreased libido, ejaculation disorders and impotence. In some patients, more than six months of treatment may be required to produce the desired increase in urine flow or improvement of symptoms.
 Finasteride is manufactured by Merck and Co., Inc., of Rahway, N.J. The drug will be sold under the trade name Proscar.
 -0- 6/22/92
 /NOTE: Attention TV broadcasters: Please use open caption for the hearing impaired./
 /CONTACT: Monica Revelle of the Food and Drug Administration, 301-443-4177/ CO: Food and Drug Administration; Merck and Co, Inc. ST: District of Columbia IN: MTC SU:


TW -- DC029 -- 2530 06/22/92 16:04 EDT
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Publication:PR Newswire
Date:Jun 22, 1992
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