Embargo:
May 18, 1998
Brussels: 4:45 pm
Atlanta: 11:45 am
Contact:
Dana Gandsman
Fleishman-Hillard
212-453-2423
[email protected]
Adam Wolf
Fleishman-Hillard
212-453-2340
[email protected]
Public Affairs
Solvay Pharmaceuticals, Inc.
(770) 578-5637
U.S. FOOD AND DRUG ADMINISTRATION APPROVES PROMETRIUM(r) (PROGESTERONE, USP) CAPSULES, ONLY ORAL FORMULATION OF MICRONIZED PROGESTERONE
Marietta, GA (May 18, 1998) -- The first oral dosage form of micronized progesterone was approved by the U.S. Food and Drug Administration. This represents a new option in oral progestogen therapy. PROMETRIUM(r) Capsules is a progesterone synthesized from yams that is structurally identical to the natural progesterone found in a woman's body. Micronization increases the absorption of progesterone. PROMETRIUM(r) Capsules received an FDA approval for treatment of secondary amenorrhea. An application is currently under review by FDA for hormone replacement therapy. Secondary amenorrhea refers to the abnormal cessation of menses in women who would otherwise be menstruating. 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. "This is excellent news for women," said Dr. Rogerio Lobo, professor and chairman, department of obstetrics and gynecology, College of Physicians & Surgeons, Columbia University. "Concomitant use of estrogens and progesterone had a favorable effect on HDL, LDL and triglycerides (compared to placebo). In addition, reports of bloating and fluid retention with micronized progesterone were no different than placebo."
Progesterone plays a key role in female physiology. "Progesterone has been overshadowed by estrogen, which is assumed by many women to be the most important reproductive hormone in their bodies," said Dr. Robert Rebar, professor and chairman, department of obstetrics and gynecology, University of Cincinnati College of Medicine. "But progesterone plays a pivotal role in women's health and as public health educators, we need to better educate women about this hormone."
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. The most common side effects of PROMETRIUM(r) Capsules are dizziness, abdominal cramping, headache, and breast pain.
Solvay Pharmaceuticals, Inc. Women's Health Portfolio
PROMETRIUM(r) Capsules, licensed for U.S. marketing from Schering Corp. in January 1998, marks the third women's health product licensed or acquired by Solvay Pharmaceuticals since June 1997. This complements the company's flagship products, ESTRATAB(r) (Esterified Estrogens Tablets, USP) and ESTRATEST(r) (Esterified Estrogens and Methyltestosterone) Tablets. U.S. licensing rights were acquired for ESTROGEL (Estradiol, USP) 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, Georgia, is a research-based pharmaceuticals 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, headquartered in Brussels, Belgium.
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Full prescribing information available upon request. Call Sonia Kimm at 212-453-2433.
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