Spectrum Pharmaceuticals, Inc., of Irvine, Calif., has announced the FDA’s acceptance of its Investigational New Drug application for ozarelix for the treatment of benign prostatic hyperplasia (BPH) and approval of a phase IIb study of the drug.
In the randomized, placebo-controlled trial, approximately 100 men suffering from BPH will receive a 15-mg dose of ozarelix or placebo on day 1 and day 15 and will be followed for six months. Efficacy will be measured by the International Prostate Symptom Score (IPSS) as well as by urine flow, residual urine volume, and quality of life. The trial was scheduled to begin last month; safety and efficacy data will be used to support a New Drug Application for ozarelix. “This trial will enable clinical investigators to familiarize themselves with ozarelix prior to the start of the pivotal Phase III trials, which are scheduled to begin in the second half of 2007,” said Rajesh Shrotriya, MD, chairman, president and CEO of Spectrum.