Atrix Laboratories, Inc announced the completion of the pivotal Eligard 45mg (leuprolide acetate for injectable suspension) Phase III clinical study for the treatment of advanced prostate cancer.
"The study has now been completed," said Dr. Steve Garrett, senior vice president of clinical research. "We are excited to know that the results are consistent with our other Eligard products. This is a positive step toward our long-term goal of expanding the success of the Eligard product line. We are now beginning to put together the New Drug Application (NDA)."
Additionally, Atrix presented interim Phase III clinical results for the company's Eligard 45mg product at the tenth annual CaP cure scientific retreat. "Researchers were genuinely excited to hear that we are developing a product intended for a six-month period of time," said Dr. Stephen J. Warren, vice president of research and development at Atrix.
Eligard 45mg is the first six-month sustained release leutenizing hormone releasing hormone (LHRH) product to complete clinical trials for the treatment of advanced prostate cancer. The company expects to submit a NDA to the US Food and Drug Administration (FDA) next year.
Sustained levels of leuprolide decrease testosterone levels to suppress tumor growth in patients with hormone-responsive prostate cancer. The Eligard products, using Atrix's proprietary Atrigel sustained-release drug delivery technology, are injected subcutaneously with a small gauge needle, forming a solid implant in the body that slowly releases leuprolide as the implant is bioabsorbed. Eligard 7.5mg, 22.5mg and 30mg products for advanced prostate cancer are currently marketed in the US by Sanofi-Synthelabo, Inc.