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| |  FDA Approves CombiPatch Hormone Replacement Therapy MIAMI, FL -- Aug. 10, 1998 -- The United States Food and Drug Administration has approved Rhone-Poulenc Rorer Pharmaceuticals Inc.’s CombiPatch(TM) (estradiol/norethindone acetate), the first hormone replacement therapy (HRT) in the U.S. to deliver a continuous dose of both estrogen and progestogen transdermally via a single patch. CombiPatch delivers the progestin norethindrone acetate (NETA) and the estrogen 17 beta-estradiol through a matrix patch technology that releases the two hormones from the patch's adhesive. This matrix technology allows CombiPatch to be clear, thin and discreet in appearance and requires changing only twice per week. "CombiPatch is great news for menopausal women," said Dr. David Archer, professor of obstetrics and gynecology, Eastern Virginia Medical School and an investigator in one of the CombiPatch clinical trials. "It provides relief from vasomotor symptoms, and the convenience of a patch delivery system." Menopause, the life stage that typically occurs in women between the ages of 45 and 55, is marked by a gradual reduction in the production of the hormone estrogen. This decrease leads to a host of symptoms -- hot flashes, night sweats, vaginal dryness -- that can dramatically alter the quality of life of menopausal women. Estrogen replacement relieves these menopausal symptoms; however, estrogen alone increases a woman's risk for endometrial hyperplasia, a condition linked to endometrial cancer. This risk can be minimized by combining the estrogen with a form of the hormone progesterone. Combination therapy of estrogen and progestin provides menopausal women with relief of symptoms and protection from endometrial hyperplasia. More than 2,500 menopausal women enrolled in six multicenter, randomized trials of CombiPatch. CombiPatch was shown to be safe and effective in relieving vasomotor symptoms, including hot flashes, night sweats and vaginal dryness. Estrogens/progestins combined should not be used in women with known or suspected pregnancy, breast cancer, estrogen-dependent neoplasia; undiagnosed abnormal genital bleeding; active thrombophlebitis, thromboembolic disorders or stroke. Estrogens have been reported to increase the risk of endometrial carcinoma in postmenopausal women. This finding refers to estrogens given without progestin. Progestins taken with estrogen drugs significantly reduce, but do not eliminate the risk of endometrial cancer that is associated with the use of estrogen.
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