EstroGel®: First Ever Transdermal Gel for Estrogen Therapy Now Available in United States
New gel formulation provides an additional delivery option for individualized estrogen therapy treatment
Marietta, GA., July 27, 2004 – Solvay Pharmaceuticals, Inc. today announced that EstroGel® (estradiol gel), the first transdermal estrogen gel in the country, is now available with a prescription to treat moderate to severe hot flashes and moderate to severe dryness, itching, and burning in and around the vagina. If using to only treat vaginal symptoms, topical vaginal products should be considered.
Approved by the U.S. Food and Drug Administration (FDA) on Feb. 9, 2004, EstroGel® is a clear, colorless, hydro-alcoholic gel that provides continuous delivery of estradiol through the skin in a non-patch transdermal form. Applied once daily on one arm from wrist to shoulder, EstroGel® has a low incidence of application site reactions. After application, the gel dries in as little as two to five minutes and is odorless.
“As a healthcare provider, I am excited about this new, transdermal delivery option for my patients that is clean and discreet,” said Dr. Alan Altman, menopause specialist, gynecologist and Harvard professor. “Healthcare providers now have an additional hormone therapy treatment option, which will allow them to individualize therapy for their patients - specifically tailoring therapy to a woman’s symptoms, medical history and delivery preference,” Altman added.
The only FDA approved estrogen therapy available in gel form, EstroGel® is also a prescribed therapy in Europe. Absorbed directly into the bloodstream, the transdermal delivery of EstroGel® ensures the body receives a consistent and continuous supply of estrogen throughout the day.
"We are extremely pleased to bring EstroGel® to market at a time when women are interested in alternative delivery options for estrogen therapy," said Harold H. Shlevin, Ph.D., president and CEO of Solvay Pharmaceuticals, Inc. "This new estrogen delivery vehicle demonstrates Solvay Pharmaceuticals’ commitment to providing safe, effective treatments for hormone therapy.”
EstroGel® joins the portfolio of Solvay Pharmaceuticals Women’s Health products – PROMETRIUM®, ESTRATEST® and ESTRATEST H.S.®
EstroGel® will be prescribed at a 1.25g daily dose; each pump delivers 64 doses. EstroGel® is packaged in a non-aerosol, metered-dose pump that delivers one dose of gel per compression.
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.
Patients should not use EstroGel® if they have unusual vaginal bleeding, currently have or have had certain cancers (including breast and cancer of the uterus), have had a stroke or heart attack in the last year, currently have or have had blood clots (e.g., in the legs), currently have or have had liver problems, are allergic to EstroGel® or any of its ingredients, are or may be pregnant or are breastfeeding.
Estrogens with or without progestins should not be used to prevent heart attacks or heart disease. In clinical studies, estrogens given in combination with progestins have been reported to increase the risk of heart attacks, stroke, breast cancer, blood clots in menopausal women. Because of these risks, the lowest dose that relieves symptoms should be used for the shortest duration possible.
Close monitoring of all women taking estrogens is important. Estrogens increase the chances of getting cancer of the uterus. Please see your healthcare professional if you are taking an estrogen and have continued or intermittent vaginal bleeding.
EstroGel® should be used in combination with a progestin in women with an intact uterus. There is no evidence to support that “natural” estrogens are safer than synthetic derived estrogens with regard to risks for endometrial cancer (lining of the uterus).
The commonly reported side effects are those typical of estrogen therapy: headache, breast pain, irregular vaginal bleeding or spotting, stomach cramps/bloating, nausea and vomiting, and hair loss.
For complete safety and prescribing information, please visit www.estrogel.com.
Solvay Pharmaceuticals, Inc. (www.solvaypharmaceuticals-us.com) of Marietta, Georgia (USA), is a research-driven pharmaceutical company that seeks to fulfill unmet medical needs in the therapeutic areas of cardiology, gastroenterology, mental health, women's health and a select group of specialized markets including men's health, antiemetics and hematology. It is a part of the global Solvay Pharmaceuticals organization whose core activities consist of discovering, developing and manufacturing medicines for human use. Solvay Pharmaceuticals is a subsidiary corporation of the worldwide Solvay Group of chemical and pharmaceutical companies headquartered in Brussels, Belgium.
For further information please contact:
Gabrielle Braswell, Manager, Public Affairs
Solvay Pharmaceuticals, Inc.
Tel: +1 770 578 5637
Fax: +1 770 578 2003
E-mail: gabrielle.braswell@solvay.com
