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Atrix Leuprogel

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Interim data from the first 51 of 120 prostate cancer patients to complete a pivotal Phase III trial of 30-day sustained release leuprolide acetate showed that it was "effective in reducing testosterone well below castrate levels with a corresponding positive response in [serum prostate specific antigen] values," according to a study abstract. Atrix plans to file an NDA for treatment of advanced prostate cancer during the first half of 2001. Atrix is enrolling patients for a trial of 90-day Leuprogel, and will follow that study with a trial of a 120-day formulation, the company sai
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