Contact:
Beverly Greenfield or Dana Gandsman
Fleishman-Hillard
(212) 453-2000
Karen Kaplan
Solvay Pharmaceuticals, Inc.
(770) 578-5637
FOR IMMEDIATE RELEASE
FDA APPROVES LOWEST EFFECTIVE ORAL DOSE OF ESTROGEN FOR PREVENTION OF OSTEOPOROSIS
Plant-Based 0.3 mg ESTRATAB (tm) Tablets Significantly Increase Bone Mineral Density, With Fewer Side Effects For Menopausal Women
Marietta, GA -- March 11, 1998 -- Solvay Pharmaceuticals, Inc., announced today that it received approval from the U.S. Food and Drug Administration to market the lowest oral estrogen dose -- 0.3 mg ESTRATAB (tm) (Esterified Estrogens Tablets, USP) -- for the prevention of osteoporosis.
In a two-year clinical trial, women on 0.3 mg ESTRATAB (tm) Tablets -- esterified estrogens synthesized from soy and yam plant sources -- showed increased bone mineral density over baseline in the spine, hip and whole body. Women taking the low dose also experienced fewer side effects, such as headache, nausea, breast tenderness, and vaginal bleeding, than women on higher doses. The FDA has also approved the 0.625 mg dose of this plant-based estrogen for the prevention of osteoporosis, a debilitating, bone-depleting disease.
"The 0.3 mg dose of this plant-based estrogen is an important new choice in osteoporosis prevention for women," says Harry K. Genant, M.D., lead author and director of the Osteoporosis Research Group at the University of California, San Francisco, School of Medicine. "Women often perceive that the risks associated with taking estrogen outweigh the benefits. Recent studies show that most menopausal women either do not take estrogen, fail to fill their prescription or stop taking estrogen before one year, which could place their long-term health in jeopardy."
The two-year study was published in the December issue of Archives of Internal Medicine and found that a daily oral dose of 0.3 mg ESTRATAB (tm) Tablets not only provided relief from vasomotor symptoms of menopause, such as hot flashes and night sweats, but also increased bone mass in the hip and spine, a predictive measure of reduction in the number of fractures that may occur as a woman ages. Patients receiving placebo continued to lose bone mass.1,2 The 0.3 mg ESTRATAB (tm) Tablets dose is half the dose of the animal-based estrogen normally prescribed by physicians for osteoporosis prevention.
National Osteoporosis Foundation Supports New Options "FDA approval of a lower dose estrogen that prevents osteoporosis is exciting news for women," says Sandra C. Raymond, executive director of the National Osteoporosis Foundation. "Women are living much longer, more active lives, but one-size-may not-fit-all when it comes to estrogen replacement therapy. It's essential that women have safe and effective options to keep their bones healthy and strong for the long-term." Osteoporosis currently affects more than 28 million Americans, most of whom are postmenopausal women. Osteoporosis is called "the silent disease" because it is usually asymptomatic and the condition often goes undetected until a fracture occurs.3 Osteoporosis causes a total of 1.5 million fractures every year in the United States and an estimated 50,000 people die each year following fracture-related complications.4
Low-Dose Plant-Based Estrogen Preserved Bones With Fewer Side Effects A two-year, multi-center, double-blind, randomized study of 406 postmenopausal patients compared ESTRATAB (tm) Tablets in 0.3 mg, 0.625 mg, and 1.25 mg (0.625mg x 2) doses of esterified estrogens with placebo. Approximately one-third of the women were hysterectomized. Each patient also received a daily supplement of 1,000 mg of calcium. Those women taking 0.3 mg ESTRATAB (tm) Tablets experienced similar protection against bone loss as women on the higher doses of estrogen.2
"An unexpected finding was that women in the 0.3 mg ESTRATAB (tm) Tablets group experienced no increase in endometrial hyperplasia, a precursor of endometrial cancer, when compared with the placebo group,1,2 " said Dr. Robert W. Rebar, professor and chairman in the department of obstetrics and gynecology at the University of Cincinnati College of Medicine. "This low dose of plant-based estrogen prevents osteoporosis -- with fewer side effects. That's a powerful message to women who are afraid to start estrogen replacement therapy for osteoporosis protection."
ESTRATAB (tm) Tablets are esterified estrogens synthesized from soy and yam plant sources. Esterified estrogens deliver primarily estrone, the principal estrogen delivered to the target tissues during menopause.5 There are no animal precursors used in ESTRATAB (tm) Tablets. Solvay Pharmaceuticals, Inc., also markets ESTRATEST (tm) (Esterified Estrogens and Methyltestosterone) Tablets, an esterified estrogen plus methyltestosterone product for the treatment of moderate to severe vasomotor symptoms associated with menopause in patients not improved by estrogen alone. Solvay Pharmaceuticals, Inc. recently acquired U.S. marketing rights to PROMETRIUM (tm) (Progesterone, USP) Capsules, a natural micronized progesterone that is currently under review by the Food and Drug Administration (FDA). U.S. licensing rights were also acquired for ESTROGEL (tm) (17-beta estradiol), a topical estrogen gel, and for a combination estrogen/progestin transdermal patch containing 17-beta estradiol/levonorgestrel; both the gel and the patch are currently undergoing Phase III clinical trials. Solvay Pharmaceuticals, Inc. of Marietta, GA, is a research-based pharmaceutical company active in the therapeutic areas of women's health, gastroenterology, and mental health. It is a member of the worldwide Solvay Group of chemical and pharmaceutical companies. Solvay SA is headquartered in Brussels, Belgium.
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