If this is not your name, click here.
| | If this is not your name, click here. | | |
| | Contact Us | Order Now | Journals | Bookstore | Register a colleague | | |
| |  Estring for Postmenopausal Urogenital Symptoms Now Available in U.S. KALAMAZOO, Mich., Jan. 14, 1997 -- Pharmacia & Upjohn (NYSE: PNU) announced today that the Estring Vaginal Ring (estradiol vaginal ring) is now available by prescription in the United States. Factory shipments have begun and Estring is available in doctors' offices and pharmacies nationwide. Estring is a soft, flexible ring for insertion into the vagina that releases a low, continuous dose of estradiol (an estrogen produced by the ovaries) for 90 days. It is indicated for treating local symptoms associated with postmenopausal atrophy of the vagina and/or the lower urinary tract. Symptoms of urogenital atrophy (UGA) can include vaginal dryness, burning, itching and painful intercourse, as well as urinary urgency and painful urination. As many as half of the 40 million postmenopausal women in the U.S. suffer to some extent from UGA symptoms. Until the availability of Estring, treatment options included estrogen tablets, transdermal patches and vaginal creams. Now women have a new option that contains a very low dose of estrogen applied directly to the tissues of the vagina and urinary tract. In clinical trials with Estring, a majority of women who had previously used another hormonal product prior to Estring stated a preference for the Estring Vaginal Ring. "Estring was designed for comfort, convenience and compliance," said William E. Walker, director of women's health care products for Pharmacia & Upjohn's North American Market Region. "It is well-liked by women in other countries and received an overall product rating of good, very good or excellent by 95% of women who used it in the U.S. clinical trial," added Walker. Estring is a slightly opaque, soft and flexible elastomer ring with an outer diameter of about two inches (55 mm) and a cross-sectional diameter of about 3/8 inch (9 mm). Estradiol particles in an inner core section of the ring dissolve and distribute by diffusion to the ring's outer layer, ensuring continuous release of estradiol to the vaginal wall for 90 days. First approved in Sweden in 1993, Estring is currently available in many countries, including the United Kingdom, Canada, New Zealand, South Africa and Switzerland. UGA may affect up to 20 million postmenopausal women in the U.S. each year, but it remains an under-recognized and under-treated condition. "Unfortunately, many women believe that postmenopausal UGA symptoms are an inevitable part of aging," said Gloria Bachmann, M.D., Chief of Ob/Gyn Service, Robert Wood Johnson University Hospital, New Brunswick, NJ. "They are not. The introduction of Estring is an important addition to the treatment options for women who have been unnecessarily suffering from this treatable condition." UGA is a medical condition that usually occurs around the time of menopause when the ovaries stop producing estrogen. It is the most consistent and inevitable consequence of long-term estrogen deficiency, and its symptoms can impact a woman's physical and psychosocial health. Unlike symptoms of menopause, such as hot flashes, symptoms of UGA do not go away with time and may lead to more serious problems. UGA symptoms range from dryness and soreness of the vagina, to painful intercourse (dyspareunia), urinary urgency and painful urination (dysuria). While the symptoms associated with menopause (hot flashes and sweating) can be best treated with systemic estrogen therapy, the local symptoms of UGA can be treated with hormone preparations such as Estring, that act locally on the tissues of the lower vaginal and urinary tract. This allows patients to use a much lower dose of estrogen. The safety, effectiveness and patient acceptability of Estring in treating UGA was compared to conjugated equine estrogen (CEE) vaginal cream in two large, multicenter clinical studies conducted in Australia and the U.S. Although efficacy results were comparable, differences emerged in the area of patient acceptability. In both studies, the majority of patients who had used another hormonal product prior to Estring stated a preference for the vaginal ring. In the Australian study, 60 of the 62 patients who had previously used a vaginal, oral or transdermal medication as treatment for UGA, preferred Estring to their previous therapy. In the U.S. study, 47 of the 90 patients who had previously used another medication preferred Estring. "Product acceptability and patient preference are important parameters to consider when treating UGA," said Dr. Bachmann, a clinical investigator during the U.S. trials for Estring. "Because UGA continues throughout life and can get progressively worse, it is critical that women choose a treatment with which they are comfortable and that they will use. For many women, Estring may be that choice." Estring and CEE creams produced similar improvements in vaginal and urinary symptoms as assessed by trial participants and investigators. For example, after 12 weeks in the U.S. study, 83% of patients treated with Estring and 82% of women treated with CEE cream reported improvement in vaginal symptoms. An overall evaluation of the severity of vaginal atrophy was performed by physicians after 12 weeks of treatment in the Australian trial. Physicians rated three-fourths of patients "improved" and approximately one-half of patients "symptom free" in each group after 12 weeks of treatment. The most common adverse events experienced by women who received Estring in these clinical studies were headache (13%), vaginal or uterine discharge (7%), back pain (6%) and genital yeast infection (6%), compared with CEE cream results of 16%, 3%, 8% and 7%, respectively. Very little estradiol from Estring is absorbed systemically, so systemic effects are minimal. However, estrogens should not be used in women with abnormal genital bleeding or any of the following known or suspected conditions: pregnancy, cancer of the breast, or estrogen-dependent neoplasia. Pharmacia & Upjohn's strong and growing presence in the area of women's health reflects the company's belief that the unmet medical needs of women are a major health problem throughout the world today. The company's leading products in this area include Depo-Provera Contraceptive Injection (sterile medroxyprogesterone acetate suspension), Provera Tablets (medroxyprogesterone acetate tablets), Ogen Tablets (estropipate tablets), Pap Plus Speculoscopy, Cleocin Vaginal Cream (clindamycin phosphate vaginal cream), Dostinex Tablets (cabergoline tablets) and Estring Vaginal Ring. Pharmacia & Upjohn, Inc. is a research-based pharmaceutically focused company dedicated to helping people around the world live longer and fuller lives. The company was formed through a merger of Pharmacia AB and The Upjohn Company and began operating in November 1995. Pharmacia & Upjohn is a provider of human health care and related products, and operates on a global basis. The company has a corporate management center in London and major research and manufacturing centers in the United States, Sweden and Italy.
|
