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| |  FDA Approves Lunelle Monthly Contraceptive Injection (Medroxyprogesterone Acetate/Estradiol Cypionate) PEAPACK, NJ -- October 6, 2000 -- The Pharmacia Corporation announced that the U.S. Food and Drug Administration (FDA) approved Lunelle™ Monthly Contraceptive Injection (medroxyprogesterone acetate and estradiol cypionate injectable suspension), the first and only once-a-month contraceptive option for women in the U.S. Lunelle, a combined hormonal injectable contraceptive method, has contraceptive benefits similar to the pill yet offers women the convenience of once-a-month dosing. "I think Lunelle is going to meet a big need for women in this country -- it has contraceptive benefits similar to the pill yet is administered only once a month," said Anita Nelson, M.D., University of California Harbor Medical Center, and U.S. clinical trial investigator. "Lunelle is more than 99 percent effective when administered as scheduled, offering women a reliable and convenient new birth control option." Lunelle was approved based on data from a pivotal clinical study of 1,103 women that compared the efficacy, safety and patient acceptability of Lunelle versus Ortho-Novum 7/7/7®, a leading oral contraceptive, at 42 sites in the U.S. The data reported no unintended pregnancies among the 782 women taking Lunelle versus two unintended pregnancies among the 321 women using the oral contraceptive after 15 cycles of use. "With my busy schedule, I find Lunelle easier than taking a pill every day. I'm out of my health care provider's office in less than 15 minutes once a month," says Roslyn Tate, a clinical study participant. Lunelle contains a combination of the hormones progestin and estrogen that is similar to the body's natural hormones. It is recommended that Lunelle be administered every month by a health care provider, not to exceed 33 days, as a single, small 0.5ml monthly intra-muscular injection. The estrogen in Lunelle is metabolized to 17 beta-estradiol - the body's natural estrogen - and at peak levels does not exceed a woman's natural cyclic levels of estrogen. Lunelle Monthly Contraceptive Injection provides monthly menstrual cycles and a quick return to ovulation, usually within two to four months. More than 50 percent of the users became pregnant during the first six months following discontinuation of Lunelle. As with the use of contraceptives containing estrogen and progestin, Lunelle is not appropriate for some women, including those with known or suspected pregnancy; current or history of thrombophlebitis or thromboembolic disorders; cerebral vascular or coronary artery disease; liver dysfunction; certain types of cancer; severe diabetes or hypertension; heavy smokers over the age of 35; and undiagnosed abnormal genital bleeding. The use of contraceptives containing estrogen is associated with an increased risk of cardiovascular side effect, which increases with heavy smoking and age, especially women over 35. Women using Lunelle are strongly discouraged from smoking. Like other hormonal contraceptives, women may experience altered bleeding patterns when using Lunelle. The average weight gain of women in the U.S. clinical trial over one year on Lunelle was four pounds. In addition, Lunelle does not protect against HIV and other sexually transmitted diseases. Related Link: The Pharmacia Corporation.
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