RELEASE: December 21, 1998 (Brussels: 4:45 pm) (Atlanta: 10:45 am)
Contact:
Sonia Kimm and Debbie Kreshover, Fleishman-Hillard, Inc., 212-453-2000, [email protected]
Karen Carlisle, Solvay Pharmaceuticals, Inc.
770-578-5581
U. S. FOOD AND DRUG ADMINISTRATION APPROVES PROMETRIUM(r) CAPSULES ORAL MICRONIZED PROGESTERONE FOR HORMONE REPLACEMENT THERAPY
NIH-Sponsored PEPI Trial Showed That PROMETRIUM" Capsules Did Not Undermine Estrogen's Positive Effects on Lipid Profiles
Marietta, GA (December 21, 1998) -- Solvay Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved for marketing the first oral micronized progesterone -- PROMETRIUM(r) (progesterone, USP) Capsules. PROMETRIUM(r) Capsules is approved by the FDA for use with estrogen therapy to prevent an overgrowth of cells in the uterine lining in postmenopausal women who have not had a hysterectomy and for treatment of secondary amenorrhea.i
PROMETRIUM(r) Capsules is a progesterone synthesized from yams that is structurally identical to endogenous (naturally-occurring) progesterone found in a woman's body. Micronization makes the progesterone easier for the body to absorb.
The Postmenopausal Estrogen/Progestin Interventions (PEPI) trial, a three-year NIH study, examined the effects of estrogen alone and in combination with both medroxyprogesterone acetate (MPA) and PROMETRIUM"š Capsules. PEPI found that, when taken alone, estrogen positively affected HDL-C, or "good cholesterol" levels. The addition of PROMETRIUM"š Capsules did not appear to negate the positive effects of oral estrogen on good cholesterol.1
In fact, women taking the estrogen and PROMETRIUM"š Capsules regimen experienced the highest increase in levels of "good cholesterol" compared to the estrogen and MPA regimens. The estrogen and PROMETRIUM"š Capsules regimen also reduced the risk of endometrial hyperplasia when compared to estrogen alone.
The suggested dose for PROMETRIUM(r) Capsules for use in HRT is 200 mg (two X 100 mg) capsules taken orally once a day, in the evening, for 12 sequential days per 28 day cycle.
Used widely in Europe, oral micronized progesterone was first introduced in France in 1980 and is marketed in more than 25 countries, including Canada. PROMETRIUM(r) Capsules was introduced in the United States in June of this year for treatment of secondary amenorrhea.
Little Known But Important Sex Hormone
Progesterone is the female sex hormone responsible for changes in the uterine lining during the second half of the menstrual cycle throughout a woman's reproductive life. Progesterone derivatives, known collectively as progestin, are commonly used in combination with estrogen when estrogen is prescribed to alleviate vasomotor symptoms of menopause or to prevent osteoporosis in women with a uterus.
Like estrogen, progesterone production drops significantly when a woman reaches menopause. A recent survey conducted by Yankelovich Partners of 1,000 women age 40 plus found that only eight percent (fewer than 1 in 10) named progesterone as one of the hormones affected as a woman enters menopause, versus 32 percent who named estrogen.
"Progesterone has been overshadowed by estrogen, which is assumed by many women to be the most important reproductive hormone in their bodies," said Dr. Jose F. Trabal, associate professor of obstetrics and gynecology at the University of Texas Health Science Center at San Antonio, and one of the PEPI trial investigators. "But progesterone plays a pivotal role in women's health, especially for women with an intact uterus."
"PROMETRIUM(r) Capsules, a recently FDA-approved progesterone, is an important new HRT option that is well-tolerated by many women, and it is structurally identical to the hormone they produce naturally.2 Importantly, PROMETRIUM(r) Capsules does not interfere with the beneficial HDL effect of estrogens to the degree that MPA does," said Dr. Trabal.
Common Side-Effects & Other Important Information
Patients who may be allergic to peanuts, suffer from severe liver disease, or who have known or suspected breast cancer, or pregnancy should not take PROMETRIUM(r) Capsules. Common side effects of PROMETRIUM(r) Capsules are breast tenderness, dizziness, abdominal bloating, and vaginal discharge.
Solvay Pharmaceuticals' Women's Health Portfolio
PROMETRIUM(r) Capsules was approved by the FDA in May 1998 for treatment of secondary amenorrhea (the absence of menstrual bleeding over a period of three months or longer in women who would normally be menstruating). PROMETRIUM(r) Capsules marks the third women's health product licensed or acquired by Solvay Pharmaceuticals since June 1997. Solvay Pharmaceuticals licensed the rights for U.S. marketing of PROMETRIUM(r) Capsules from Schering Corporation in January 1998. This complements the company's flagship products, ESTRATAB" (Esterified Estrogens, USP) Tablets and ESTRATEST" (Esterified Estrogens and Methyltestosterone) Tablets. Solvay Pharmaceuticals received FDA approval in March of this year to market ESTRATAB" Tablets as the lowest oral estrogen dose for the prevention of osteoporosis.
Another product recently acquired by Solvay Pharmaceuticals is ESTROGEL" (estradiol, USP) Transdermal Gel, a topical estrogen undergoing Phase III clinical trials for the systemic treatment of vasomotor symptoms such as hot flashes and night sweats.
In October 1997, Solvay Pharmaceuticals acquired exclusive U.S. and Canadian licensing rights for a technologically advanced combination estrogen/progestin hormone replacement matrix patch undergoing Phase III clinical trials for relief of moderate to severe vasomotor symptoms.
Solvay Pharmaceuticals 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 SA Group of chemical and pharmaceutical companies, headquartered in Brussels, Belgium.
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