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| |  FDA Approves Vivelle (estradiol transdermal system) For Postmenopausal Osteoporosis MIAMI, FL -- August 18, 2000 -- Doctors now have a new, effective treatment option to help patients reduce their risk of developing postmenopausal osteoporosis. The U.S. Food and Drug Administration (FDA) has approved an existing transdermal estrogen patch, marketed by Novogyne Pharmaceuticals, a joint venture between Noven Pharmaceuticals, Inc. and Novartis Pharmaceuticals Corporation, for the prevention of postmenopausal osteoporosis. The patch, sold under the Vivelle (estradiol transdermal system), has been available for the treatment of menopausal symptoms since March 1996. Vivelle is available by prescription and utilizes Noven's transdermal matrix technology. The product delivers estradiol, the primary estrogen produced by the ovaries, through a patch that is applied twice weekly. Vivelle is now indicated for the prevention of osteoporosis and currently available in four dosage strengths (0.0375, 0.05, 0.075 and 0.1 mg/day). A new low dose of Vivelle, 0.025 mg/day, is expected to be available in U.S. pharmacies in late 2000. The 0.025 mg/day dosage strength is about the size of a quarter. After menopause, a woman can lose up to 20 percent of her bone mass, making her more susceptible to osteoporosis. In the U.S., 80 percent of those suffering from osteoporosis are women. "Use of hormone replacement therapies, such as Vivelle, can help reduce the risk of osteoporosis and, at the same time, help women experiencing menopause ease menopausal symptoms such as hot flashes, night sweats and vaginal dryness," said W. Neil Jones, Executive Director Marketing and Sales at Noven Pharmaceuticals, Inc. In clinical trials, systemic adverse events with Vivelle (estradiol transdermal system) and placebo, respectively, include headache (36 percent vs. 30 percent), breast tenderness (4.9 percent vs. 1.1 percent), fluid retention (3.8 percent vs. 2.2 percent) and back pain (13 percent vs. 4.5 percent). Local application site reactions with Vivelle were approximately 9 percent vs. 10 percent in patients treated with placebo; most cases were considered mild, none were considered severe. Estrogens should not be used in individuals with known or suspected pregnancy, undiagnosed abnormal genital bleeding, breast cancer, estrogen- dependent neoplasia, active thrombophlebitis or thromboembolic disorders, or a documented history of these conditions. Estrogens have been reported to increase the risk of endometrial carcinoma in postmenopausal women. Related Links: Noven Pharmaceuticals, Inc. and Novartis Pharmaceuticals Corporation.
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