First US Transdermal Gel for Estrogen Therapy Approved
(Marietta, GA., Feb. 10, 2004) - Solvay Pharmaceuticals, Inc. announced that
the US Food and Drug Administration (FDA) has approved EstroGel® (estradiol
gel), the first estrogen therapy transdermal gel available in the US to treat
moderate to severe menopausal symptoms, including hot flashes as well as vulvar
and vaginal atrophy. EstroGel® is a clear, odorless gel that delivers estrogen
replacement (estradiol) in a non-patch transdermal form. This enables a consistent
and continuous supply of estrogen.
EstroGel® provides women with a safe and easy-to-use treatment option. EstroGel®
has been a prescribed therapy for more than 25 years in Europe. It will be available
with a prescription in pharmacies throughout the United States by mid-2004.
Applied once daily on one arm from wrist to shoulder, EstroGel® avoids first
pass metabolism in the liver and minimizes application site skin irritation.
The gel dries in as little as two to five minutes. EstroGel® will be prescribed
at a 1.25g (0.75 mg estradiol) daily dose. EstroGel® is packaged in a non-aerosol,
metered-dose pump that is designed to deliver 1.25g (0.75 mg estradiol) of gel
"With the approval of EstroGel®, women and healthcare professionals now have
an additional hormone therapy option. EstroGel® will offer healthcare providers
the opportunity to individualize a woman's therapy to help manage vasomotor
symptom relief," said Harold H. Shlevin, Ph.D., president and CEO of Solvay
Pharmaceuticals, Inc. "The FDA's approval of EstroGel® provides Solvay Pharmaceuticals
with a complete line of women's health products, offering women and their healthcare
professionals a range of first and second-line menopausal therapeutic options,
as well as adjunctive therapy for women requiring endometrial protection."
Data supporting the efficacy and tolerability of EstroGel® in reducing the
frequency and severity of moderate-to-severe vasomotor symptoms was demonstrated
in a 12-week, double-blind, randomized, placebo-controlled, multicenter study.
The study analyzed the effects of EstroGel® on 145 healthy, postmenopausal women
suffering from moderate-to-severe hot flashes.
"[EstroGel®] represents a promising new alternative delivery system for ET
in menopausal women," said Dr. David Archer, lead investigator of the study.
The use of unopposed estrogens in women with a uterus increases their risk
of endometrial cancer. Oral estrogens with or without progestins should not
be used for the prevention of cardiovascular disease. The Women's Health Initiative
(WHI) study reported increased risks of myocardial infarction, stroke, invasive
breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal
women (50 to 79 years of age) during 5 years of treatment with oral conjugated
estrogens (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg)
relative to placebo. Other doses of conjugated estrogens with medroxyprogesterone
and other combinations and dosage forms of estrogens and progestins were not
studied in the WHI clinical trials, and in the absence of comparable data, these
risks should be assumed to be similar. Because of these risks, estrogens with
or without progestins should be prescribed at the lowest effective doses and
for the shortest duration consistent with treatment goals and risks for the
Estrogens are contraindicated for patients with known or suspected pregnancy,
breast cancer,active thrombophlebitis, or thromboembolic disorders.
For more information about menopause, click here.
Created: 2/28/2004  - Donnica Moore, M.D.