Drug manufacturer Pfizer announced today that the U.S. Food and Drug Administration (FDA) has given approval for the release of depo-subQ provera 104 to be prescribed for the management of pain associated with endometriosis, a gynecological condition that affects one in ten women of reproductive age. The medicine is the first new treatment option for endometriosis pain in 15 years.
Endometriosis occurs when excess endometrial tissue of the uterus migrates and implants in other areas of the body, usually on the ovaries, fallopian tubes and other organs in the pelvic region. The condition causes pelvic pain, particularly during the menstrual cycle and is one of the top three causes of infertility.
Clinical data has shown that Depo-subQ provera 104 which received FDA approval for use as a contraceptive in December 2004, is equally as effective for treating the pain caused by endometriosis as leuprolide acetate is and has significantly less impact on bone mineral density, and lower incidence and severity of menopausal symptoms, such as hot flashes. Current treatment options include pain medication, surgery or hormone therapy, including oral contraceptives or gonadotropin-releasing hormone agonists, such as Lupron.
Dr. Ray Urbanski, Pfizer medical director says the availability of the drug is good news for the millions of women who suffer from pain caused by endometriosis, and women will now be able to access pain relief as effective as a commonly-prescribed treatment but with fewer hot flashes and less bone mineral density loss.
The study over 18-months involved 274 patients and they were given injections of the drug every three months, which was statistically equivalent to Lupron every three months across all endometriosis-associated pain categories including pelvic pain, pelvic tenderness, painful periods, painful intercourse, and hardening/thickening of tissue. Lupron-treated patients showed significant decreases from baseline in both femur and lumbar spine bone mineral density at month 18, while patients taking depo-subQ provera 104 did not.
Injections four times a year was effective in halting menstruation, which results in thinner, more compact endometrial tissue and this then stops the growth of endometrial implants, relieving endometriosis-associated pain. Depo-subQ provera 104 is expected to be widely available in May 2005.
As a contraceptive which is injected every three months, it has proven to be more effective than the original DEPO-PROVERA Contraceptive Injection, but with 30 percent less hormone.
Women using the drug may lose significant bone mineral density, bone loss is greater with increasing duration of use and may not be completely reversible. Whether the use of depo-subQ provera 104 during adolescence or early adulthood, a critical period of bone accretion, will increase the risk of osteoporotic fracture in later life is unclear at this stage. It should only be used as a long-term birth control method (e.g., longer than two years) if other birth control methods are inappropriate. The most common side effect experienced was irregular menstrual bleeding, typically followed by amenorrhea (loss of monthly menstrual period). The average weight gain after one year of use was 3.5 pounds.
Depo-subQ provera 104 does not protect against sexually transmitted diseases, including HIV (AIDS).
Depo-subQ provera 104 is not suitable for patients with known or suspected pregnancy or with undiagnosed vaginal bleeding, known or suspected breast malignancy, current or past thromboembolic or cerebral vascular disorders, or significant liver disease. Depo-subQ provera 104 may be considered among the possible risk factors for the development of osteoporosis. The risk of osteoporosis should be assessed for women with multiple risk factors.