(FDA)美國食品藥物管理局 2002年3月批准上市

    Eligard:治療前列腺癌的Eligard 7.5毫克劑量 抗癌新療法獲FDA批准

    Drugs Approved by the FDA
    Drug Name: Eligard (leuprolide acetate)
    The following information is obtained from various newswires, published medical journal articles, and medical conference     presentations.

    Company: Atrix Laboratories
    Approval Status: Approved January 2002
    Treatment for: Advanced prostate cancer

    General Information
    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.

    Side Effects
    Adverse events reported from clinical testing of Eligard include (but are not limited to) the following:

    Malaise
    Fatigue
    Dizziness
    Hot flashes/sweats
    Gastroenteritis
    Colitis
　

    Mechanism of Action
    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)

    Additional Information
    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