FDA Approves Depo-Subq Provera 104TM for Management of Endometriosis Pain, Pfizer

(2005-03-31)

Pfizer Inc announced today that it has received US Food and Drug Administration approval for depo-subQ provera 104TM (medroxyprogesterone acetate injectable suspension) 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.

Depo-subQ provera 104 is a long-acting injectable contraception and a new formulation of medroxyprogesterone acetate, which is the same active ingredient as DEPO-PROVERA® Contraceptive Injection (medroxyprogesterone acetate injectable suspension).

Endometriosis occurs when excess endometrial tissue of the uterus migrates and implants in other areas of the body-most commonly on the ovaries, fallopian tubes and other organs in the pelvic region. The major symptom of endometriosis is pelvic pain, particularly during the menstrual cycle. Endometriosis is one of the top three causes of infertility-30 to 40 percent of women with the disease are infertile-though the exact link is unknown.

Clinical data showed that depo-subQ provera 104 is equally as effective for treating pain caused by endometriosis as leuprolide acetate (LA), marketed as Lupron Depot® (leuprolide acetate for depot suspension), with significantly less decline in 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.

"The availability of depo-subQ provera 104 is good news for the millions of women who suffer from pain caused by endometriosis, a condition that tends to worsen over time if not treated," said Dr. Ray Urbanski, Pfizer medical director. "Women will now have the opportunity to get pain relief as effective as a commonly-prescribed treatment but with fewer hot flashes and less bone mineral density loss."

In an 18-month study involving 274 patients, depo-subQ provera 104 administered every three months 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.

Administered by subcutaneous injection four times a year (every 12 to 14 weeks), depo-subQ provera 104 is effective in halting menstruation, which results in thinner, more compact endometrial tissue. This in turn halts the growth of endometrial implants, relieving endometriosis-associated pain. Depo-subQ provera 104 is expected to be widely available in May 2005.

Depo-subQ provera 104 received FDA approval for use as a contraceptive in December 2004. Injected every three months, depo-subQ provera 104 provides better efficacy than the original DEPO-PROVERA Contraceptive Injection, but with 30 percent less hormone.

Women who use depo-subQ provera 104 may lose significant bone mineral density. Bone loss is greater with increasing duration of use and may not be completely reversible. It is unknown if use of depo-subQ provera 104 during adolescence or early adulthood, a critical period of bone accretion, will reduce peak bone mass and increase the risk of osteoporotic fracture in later life.

Depo-subQ provera 104 should be used as a long-term birth control method (e.g., longer than two years) only if other birth control methods are inadequate.

In the clinical trials, the most common side effect 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 contraindicated in 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.

Depo-subQ provera 104 does not require dosing adjustments based on body type, body mass index or weight.

Lupron Depot® is a registered trademark of TAP Pharmaceutical Products Inc.

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