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Benign Prostatic Hypertrophy
U.S. FDA accepts Spectrum's ozarelix IND, approves protocol in benign prostate hypertrophy
January 29th, 2007
Spectrum Pharmaceuticals, Inc. (SPPI) announced that the U.S. Food and Drug Administration (FDA) has accepted the company's investigational new drug (IND) application for ozarelix in benign prostatic hypertrophy (BPH) and that the FDA has approved the protocol for the phase 2b study of ozarelix for the treatment of BPH. Claus Roehrborn, UT Southwestern Medical Center, Dallas, Department of Urology, will be the lead investigator. The phase 2b study is a randomized, placebo-controlled trial of ozarelix involving approximately 100 men suffering from BPH. In this trial, the men will be dosed with 15 mg of ozarelix or placebo on day 1 and day 15 and will...
Source: Biotech Business Week (2007-01-29)
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