Vivelle(R) (Estradiol Transdermal System) Receives Indication for Osteoporosis Prevention
Estrogen Replacement Patch Offers Dosing Flexibility
While Now Helping to Prevent Bone Loss
MIAMI, Aug. 17 /PRNewswire/ -- 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 brand name, 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% 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% vs. 30%), breast tenderness (4.9% vs. 1.1%), fluid retention (3.8% vs. 2.2%) and back pain (13% vs. 4.5%). Local application site reactions with Vivelle were approximately 9% vs. 10% 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. Vivelle is marketed by Novogyne Pharmaceuticals, a joint venture between Novartis Pharmaceuticals Corporation of East Hanover, New Jersey, and Noven Pharmaceuticals, Inc. of Miami, Florida. Noven Pharmaceuticals, Inc., headquartered in Miami, Florida, is a leader in the development of transdermal and transmucosal drug delivery systems and technologies. Noven has developed and presently manufactures a series of leading-edge products, including the world's smallest estrogen transdermal delivery system, the United States' only combination estrogen/progestin transdermal delivery system, and the first transmucosal patch approved for marketing by the U.S. Food and Drug Administration. With a wide range of additional products in development, Noven is committed to becoming the world's premier developer, manufacturer, and marketer of transdermal and transmucosal drug delivery systems. Novartis Pharmaceuticals Corporation is an affiliate of Novartis, A.G. (NYSE: NVS). Novartis, A.G. is a world leader in healthcare with core businesses in pharmaceuticals, consumer health, generics, eye-care, and animal health. In 1999, the Group (including Agribusiness) achieved sales of CHF 32.5 billion and invested more than CHF 4.2 billion in R&D. Headquartered in Basel, Switzerland, Novartis employs about 82,000 people and operates in over 140 countries around the world. The Group recently announced plans to spin- off its Crop Protection and Seeds sectors and to merge them with the agrochemicals business of AstraZeneca in the second half of 2000. Vivelle Prescribing Information is available at www.novogyne.com, or by calling (888) NOW-NOVA.
SOURCE Noven Pharmaceuticals, Inc.
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