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The company said clinical trials of silodosin for benign prostatic hyperplasia met primary and secondary endpoints while showing the drug was well tolerated. Benign prostatic hyperplasia is an enlarged prostate without cancer.
Patients given silodosin over 12 weeks showed statistically significant improvement in the obstruction and irritation caused by their enlarged prostate glands compared with placebo. Patients also saw improvement in the flow of their urine.
The company plans to wrap up a one-year safety study on the drug in the fall, and submit a marketing application with the Food and Drug Administration in the first half of 2008.