Magazine article Drug Topics

Merck's BPH Drug Gets New Labeling

Magazine article Drug Topics

Merck's BPH Drug Gets New Labeling

Article excerpt

Studies showing that Proscar (finasteride, Merck & Co.), a drug therapy for the treatment of benign prostatic hyperplasia (BPH), increases urinary flow and improves symptoms in men have been incorporated into the product's new labeling.

Although it is well known that finasteride, which has been available since 1992, reduces the size of the enlarged prostate gland, the drug's effect on BPH symptoms and urinary flow rate has, until now, been unclear.

The new labeling, which is based on two 36-month open-label extension studies, states that the drug improves symptoms and urinary flow in about 60% of patients. The statistically significant improvement in urinary flow rate and BPH symptoms was evident at two weeks, the new labeling states.

New data incorporated into the product labeling also show that the effects of finasteride on reduction in prostate size, increased urinary flow, and improvement in symptoms were sustained for three years.

"This drug is unique because, unlike other medical treatments for benign prostate enlargement, clinical trials for Proscar show that the drug shrinks the enlarged prostate, along with increasing urinary flow and improving urinary symptoms in the majority of men, suggesting an arrest in the disease process," said Elizabeth Stoner, M. …

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