Keywords:
Troubling Gap in Hormone Therapy Use Not Medically Justified
* Clinical Study of Duramed's Cenestin Demonstrates Different Races Respond Equally
to Hormone Therapy
Federal Survey Shows Gaps Persist Between Races in Hormone Therapy Usage
Despite cultural and ethnic gaps in the likelihood of women to use hormone replacement
therapy, clinical studies completed by Duramed Pharmaceuticals (Nasdaq: DRMD) show that
women of various ethnic backgrounds and body types respond equally well to Cenestin(R)
(synthetic conjugated estrogens, A) Tablets.
A clinical trial completed by Duramed last year proved that women of various races
experienced a similar response to treatment by estrogen replacement therapy. After 12
weeks of treatment with Cenestin, there were no statistically significant differences in
response between Caucasians and African Americans. The study included African American,
Caucasian and women of other races whose body weight ranged from 109 to 271 pounds.
"Monday's announcement from the National Center for Health Statistics showed that
African Americans or Mexican Americans are far less likely than Caucasian women to use
hormone replacement therapy. The troubling gap is not justified medically and needs to be
eliminated. American women who take Cenestin can be certain that their hormone replacement
therapy is consistently efficacious despite racial and body mass differences," said
Duramed Chairman and Chief Executive Office E. Thomas Arington. "Duramed designed
this trial with the goal in mind of measuring estrogen's effectiveness in women of various
races and physical types. This unique clinical trial specifically included segments of
America's female population that, all too often, are overlooked in scientific
studies."
About the Company
Duramed Pharmaceuticals develops, manufactures and markets prescription drug products. The
company's business strategy emphasizes products with attractive market opportunities and
potentially limited competition due to technological barriers to entry, focusing on
women's health and the hormone replacement therapy market. On March 24, 1999, the FDA
approved the company's first branded product, Cenestin(R) (synthetic conjugated estrogens,
A) Tablets, for the treatment of moderate-to-severe vasomotor symptoms associated with
menopause.
On October 6, 1999, Duramed entered into an alliance with Solvay Pharmaceuticals, Inc. to
jointly promote three of the companies' hormone products to obstetricians and
gynecologists across the United States: Duramed Pharmaceuticals' Cenestin and Solvay
Pharmaceuticals' Estratest(R) (1) and Prometrium(R) (2).
Duramed's containment manufacturing facility for the production of hormones -- with
enclosed product flow and state-of-the-art environmental controls -- ensures purity,
stability and tablet uniformity for Cenestin and other hormone products. While Duramed's
primary focus will be solid oral dose hormones, the company's other areas of concentration
-- controlled release technology and oncology -- continue to represent attractive market
opportunities that will be pursued, as appropriate.
The company's stock is traded on Nasdaq using the symbol DRMD. Additional information
about the company can be found on the World Wide Web at www.duramed.com and
www.cenestin.com .
(1) Estratest is a trademark of Solvay Pharmaceuticals.
(2) Prometrium is a trademark of Solvay Pharmaceuticals.
Like all estrogen drug products, CENESTIN(R), and ESTRATEST(R)/ESTRATEST(R) H.S. Brand
Tablets 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 endometrial carcinoma in postmenopausal women with an intact uterus. The most
common adverse events reported in clinical experience with CENESTIN included headache,
insomnia, asthenia, nervousness, paresthesia, and depression. The most common adverse
events reported with ESTRATEST(R)/ESTRATEST(R) H.S. Brand Tablets include those typical of
estrogen therapy (such as breast tenderness, headache, nausea, edema and abdominal pain)
and of androgen treatment (including hair loss, acne and hirsutism). Common side effects
of PROMETRIUM(R) Capsules are breast tenderness, dizziness, abdominal bloating, and
vaginal discharge. For additional information on CENESTIN(R), ESTRATEST(R) Brand Tablets
or PROMETRIUM(R) Capsules, please see full prescribing information.
For independent comments and discussions on Hormone Therapy, please go to
HairSite
Female Hair Loss Discussion Group |
