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Esclim Estradiol Patch Available In U.S. For Menopause Symptoms SAN DIEGO, CA -- November 12, 1999 -- Women First HealthCare, Inc. today announced it will market the Esclim™ estradiol transdermal system, offering American women a new option in controlling the symptoms of menopause. Available this month in U.S. pharmacies by prescription only, Esclim is indicated for the treatment of moderate to severe vasomotor symptoms, such as hot flashes, associated with menopause. Esclim is prescribed to more women in France than any other estrogen patch. The system was developed and is manufactured by Laboratoires Fournier, S.A., a pharmaceutical research and development company based in Dijon, France. Approved in 20 countries, Esclim was studied in more than 20 clinical trials involving over 2,400 women. The U.S. market for hormone replacement therapy (HRT) products was $1.7 billion in 1998, with transdermal patch products accounting for $197 million, according to IMS Health. Women First estimates that the market for transdermal HRT products is expected to grow by an average of 26 percent each year and is expected to reach approximately $491 million in 2002, based on data from IMS Health and estimates from Medical Data International, Inc. "Esclim is an excellent addition to our hormonal management product line that serves the unique needs of a large and growing population of women," said David F. Hale, president and chief executive officer of Women First HealthCare. "Esclim underscores our commitment to provide product choice for midlife women. While some women prefer taking pills, others like the convenience of an estrogen patch, especially one that is comfortable to wear." Hale added that, in the year 2000, Women First expects to be the only company in the U.S. offering women the choice of oral, transdermal and combination hormonal therapies. The Esclim system is designed to release small amounts of 17 beta estradiol, the principal form of estrogen produced naturally by a woman’s ovaries prior to menopause, through the skin on a continuous basis. Known as the first stretchable patch, Esclim comes in the widest range of dosage strengths available, including a more desirable low dosage of 0.025 mg/day, as well as dosages of 0.0375, 0.05, 0.075 and 0.1 mg/day, thus giving physicians and clinicians the alternatives necessary to customize patient therapy. The patch, which is worn constantly and replaced every three to four days, offers comfort and convenience with its soft flexible foam backing that moves with the skin, and its adhesion properties that accommodate the needs of most active women. As with other estrogen replacement therapies, the most commonly reported side effects typically include breast tenderness, headache, nausea and abdominal pain. In controlled clinical studies with Esclim, the most commonly reported adverse events were topical reactions limited to the site of application. In general these reactions caused patients little or no discomfort and led to premature discontinuation of treatment in 0.9 percent of patients in these trials. HRT is not suitable for all women. Women should talk to their health care professional before starting HRT. Estrogens should not be used in women with known or suspected pregnancy, breast cancer, or estrogen-dependent neoplasia; undiagnosed abnormal genital bleeding, active thrombophlebitis or thromboembolic disorders. Estrogens have been reported to increase the risk of serious side effects including thromboembolic disorders, cardiovascular disease and endometrial carcinoma in postmenopausal women. Progestins taken with estrogen drugs significantly reduce but do not eliminate the risk of endometrial cancer that is associated with the use of estrogen. Women First, a specialty health care company, has an exclusive agreement with Laboratoires Fournier, S.A. to distribute, promote and sell Esclim in the U.S. and Puerto Rico. E-mail this page to a friend or colleague! To print, use this version