FDA accepts Spectrum's IND for ozarelix

The US Food and Drug Administration (FDA) has accepted California-based Spectrum Pharmaceuticals' Investigational New Drug application for ozarelix in benign prostate hypertrophy (BPH) and has approved the protocol for the Phase IIb study of ozarelix for the treatment of BPH. Claus Roehrborn from the UT Southwestern Medical Center at Dallas, Department of Urology, will serve as the lead investigator.

The Phase IIb study is a randomized, placebo-controlled trial of ozarelix involving approximately 100 men suffering from BPH. In this, the subjects will be dosed with 15mg of ozarelix or placebo on days one and 15 and will be followed for six months following dosing. The primary endpoint of the study will be the improvement of BPH symptoms as measured by the International Prostate Symptom Score, the standard method of assessing BPH symptoms. The program will also measure urine flow, residual urine volume and quality of life. This trial will begin in January 2007 and data from this is expected to be available in around six months time after it is initiated. Safety and efficacy results from this trial will be used to support a New Drug Application for ozarelix.