The USFDA has accepted Spectrum Pharmaceuticals, Inc. (Nasdaq: SPPI)’s Investigational New Drug (IND) application for ozarelix in Benign Prostate Hypertrophy (BPH) and has approved the protocol for the Phase 2b study of ozarelix for the treatment of BPH.
UT Southwestern Medical Center at Dallas, Department of Urology’s Dr. Claus Roehrborn will serve as lead investigator.
The Phase 2b study is a randomized, placebo-controlled trial of ozarelix involving approximately 100 men suffering from BPH, wherein men will be dosed with 15 mg of ozarelix or placebo on day 1 and day 15 and will be followed for 6 months following dosing.
The trial will evaluate safety and assess the clinical efficacy of ozarelix as a treatment for BPH. Commencing January 2007, data from this trial is expected to be available after approximately.
The resulting safety and efficacy data from this trial will then be used to support a New Drug Application (NDA) for ozarelix.
Read the full press release from Spectrum Pharmaceuticals, Inc.
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