Eligard 7.5mg (formerly Leuprogel One-Month Depot) has been approved by the FDA for the treatment of advanced prostate cancer. Eligard (for subcutaneous injection) is designed to deliver 7.5 mg of leuprolide acetate at a controlled rate over a one-month therapeutic period.
Atrix is developing various leuprolide acetate formulations based on the company's Atrigel drug delivery system. The product is injected into the body in a liquid form, where it solidifies and continuously releases a predetermined dose of leuprolide acetate. Sustained levels of leuprolide, a luteinizing hormone-releasing hormone (LHRH) agonist, decrease testosterone to suppress tumor growth in patients with hormone-responsive prostate cancer.
Adverse events reported from clinical testing of Eligard include (but are not limited to) the following:
Leuprolide acetate, an LH-RH agonist, acts as a potent inhibitor of gonadotropin secretion when given continuously in therapeutic doses. Animal and human studies indicate that after an initial stimulation, chronic administration of leuprolide acetate results in suppression of ovarian and testicular steroidogenesis. This effect is reversible upon discontinuation of drug therapy.
In humans, administration of leuprolide acetate results in an initial increase in circulating levels of luteinizing hormone (LH) and follicle stimulating hormone (FSH), leading to a transient increase in levels of the gonadal steroids (testosterone and dihydrotestosterone in males, and estrone and estradiol in premenopausal females). However, continuous administration of leuprolide acetate results in decreased levels of LH and FSH. In males, testosterone is reduced to below castrate threshold. These decreases occur within two to four weeks after initiation of treatment. Long-term studies have shown that continuation of therapy with leuprolide acetate maintains testosterone below the castrate level for up to seven years. (from Eligard FDA Label)
Sanofi-Synthelabo is Atrix's marketing partner for the Eligard product line. Atrix is developing two additional Eligard products that release leuprolide acetate over a period of three and four months.
For more information on Eligard, please visit Atrix Laboratories.