Atrix Laboratories, Inc. announced that Sanofi-Synthelabo Canada, Atrix's licensee, has received notice of compliance (NOC) from the Therapeutic Products Directorate of Health Canada for Eligard 30mg (leuprolide acetate for injection), a four-month sustained-release prostate cancer product. The NOC permits this product to be sold in Canada. Sanofi-Synthelabo Canada will be responsible for marketing the product in Canada.
"With approval of the four-month product, our product line now is on parity with other leuprolide acetate products offered in Canada," said Michael Duncan, Atrix's vice president and general manager. "Sanofi-Synthelabo Canada is now working to launch the one-, three-, and four-month products by May of this year. The launch will be on a province by province basis as the products receive formulary approval."
Eligard 7.5mg and 22.5mg one- and three-month prostate cancer products were approved for marketing in Canada in November 2003. The Eligard product line is indicated for the palliative treatment of hormone sensitive advanced prostate cancer. Leuprolide acetate is a lutenizing hormone releasing hormone (LHRH) agonist. Sustained levels of leuprolide acetate decrease testosterone levels to suppress tumor growth in patients with hormone-responsive advanced prostate cancer. The liquid Eligard product, using Atrix's proprietary Atrigel sustained-release drug delivery technology, is injected subcutaneously with a small gauge needle, forming a solid implant in the body that slowly releases leuprolide as the implant is bioabsorbed.
Eligard products, like other hormonal treatments for prostate cancer, cause a transient increase in serum concentrations of testosterone during the first week of treatment. Patients may experience worsening of symptoms or onset of new signs and symptoms during the first few weeks of treatment. Response to these products should be monitored by measuring serum concentrations of testosterone and prostate specific antigen periodically.