Glaxo says prostate drug safe

LONDON (Reuters) - Drugs giant GlaxoSmithKline (LSE: GSK.L - news) says late-stage clinical trials show its dutasteride treatment for swollen prostate glands, one of the most common complaints in men, is both safe and effective.

A spokesman for Europe's biggest pharmaceutical firm said on Monday the drug had been filed for approval by regulators in both the United States and Europe and should be launched in the second half of this year.

Benign prostate hyperplasia -- or progressive swelling of the prostate gland affects around 75 percent of men over 50. The condition squeezes and distorts the urethra as it passes through the prostate gland, making it difficult to pass urine.

GlaxoSmithKline said Phase III clinical trials involving over 4,000 patients showed dutasteride had a long-term positive impact on benign prostate hyperplasia compared with placebo.

Analysts at Lehman Brothers forecast peak sales for the drug of around $500 million (350 million pounds) a year by 2009.

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