Agency Grants New Indication for Bothersome Vaginal Symptom Associated With Menopause
COLLEGEVILLE, Pa., Nov. 13 /PRNewswire-FirstCall/ -- PREMARIN(R) (conjugated estrogens) Vaginal Cream 0.5 g has been approved by the U.S. Food and Drug Administration (FDA) for a new indication and a new less frequent twice-weekly dosing regimen to treat moderate to severe postmenopausal dyspareunia (painful sexual intercourse) announced Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE).
"This approval is welcome news, especially when you consider that more than one in four untreated postmenopausal women experience dyspareunia, a symptom of vulvar and vaginal atrophy, which typically does not subside without treatment," says Gloria Bachmann, M.D., Director of the Women's Health Institute at the University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School, New Brunswick, N.J. and Chief of the OB/GYN service at the teaching hospital.
PREMARIN Vaginal Cream is the first vaginal estrogen therapy indicated for the treatment of moderate to severe dyspareunia due to menopause. A low-volume regimen of PREMARIN Vaginal Cream can treat painful intercourse due to menopause, restore vaginal tissue, and reverse changes in the vagina that occur with menopause.
The approval is based on efficacy results from a multicenter clinical study that included a 12-week randomized, double-blind placebo phase followed by a 40-week open-label phase. Results from the 12-week phase showed that both low-dose regimens of PREMARIN Vaginal Cream (0.5 g daily [21 days on/7 days off] or twice weekly) significantly improved the dyspareunia score versus placebo at 12 weeks. In this study, dyspareunia was one of the most bothersome symptoms of vulvar and vaginal atrophy. Endometrial safety was assessed in women who completed the 52-week study period and had evaluable endometrial biopsies. There were no reports of endometrial hyperplasia or endometrial carcinoma in these women in either regimen.
"This new indication for PREMARIN Vaginal Cream, with a low volume of 0.5 g and two different dosing regimens -- 21 days on/7 days off or twice weekly -- gives health care professionals and women a new option in treating moderate to severe dyspareunia due to menopause," says Eileen Helzner, M.D., Assistant Vice President, Global Medical Affairs, Wyeth Pharmaceuticals.
PREMARIN Vaginal Cream is only available by prescription.
Important Safety Information
What is the most important information you should know about PREMARIN Vaginal Cream (a cream of estrogens)?
PREMARIN(R) Vaginal Cream is used after menopause to treat menopausal changes in and around the vagina and to treat painful intercourse caused by menopausal changes of the vagina.
PREMARIN Vaginal Cream should not be used if you have unusual vaginal bleeding, have or had cancer of the breast or uterus, had a stroke or heart attack, have or had blood clots or liver problems, are allergic to any of the ingredients in PREMARIN Vaginal Cream, or think you may be pregnant.
The most commonly reported side effects of PREMARIN Vaginal Cream included headache, infection, abdominal pain, accidental injury, and vaginitis.
About Wyeth Pharmaceuticals
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women's health care, infectious disease, gastrointestinal health, central nervous system, inflammation, transplantation, hemophilia, oncology, vaccines and nutritional products.
Wyeth is one of the world's largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing and marketing of pharmaceuticals, vaccines, biotechnology products, nutritionals and non-prescription medicines that improve the quality of life for people worldwide. The Company's major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health. For additional information about the company, please visit http://www.wyeth.com.
The statements in this press release that are not historical facts are forward-looking statements that are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, the inherent uncertainty of the timing and success of, and expense associated with, research, development, regulatory approval and commercialization of our products and pipeline products; government cost-containment initiatives; restrictions on third-party payments for our products; substantial competition in our industry, including from branded and generic products; emerging data on our products and pipeline products; the importance of strong performance from our principal products and our anticipated new product introductions; the highly regulated nature of our business; product liability, intellectual property and other litigation risks and environmental liabilities; uncertainty regarding our intellectual property rights and those of others; difficulties associated with, and regulatory compliance with respect to, manufacturing of our products; risks associated with our strategic relationships; economic conditions including interest and currency exchange rate fluctuations; changes in generally accepted accounting principles; trade buying patterns; the impact of legislation and regulatory compliance; risks and uncertainties associated with global operations and sales; and other risks and uncertainties, including those detailed from time to time in our periodic reports filed with the Securities and Exchange Commission, including our current reports on Form 8-K, quarterly reports on Form 10-Q and annual report on Form 10-K, particularly the discussion under the caption "Item 1A, Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2007, which was filed with the Securities and Exchange Commission on February 29, 2008. The forward-looking statements in this press release are qualified by these risk factors. We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.
-- Estrogens may increase the chances of getting cancer of the uterus. -- Report any unusual vaginal bleeding right away while you are using PREMARIN Vaginal Cream. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your health care provider should check any unusual vaginal bleeding to find the cause. -- Do not use estrogens with or without progestins to prevent heart disease, heart attacks, strokes, or dementia. -- Using estrogens with or without progestins may increase your chances of getting heart attacks, strokes, breast cancer, and blood clots. Using estrogens, with or without progestins, may increase your risk of dementia, based on a study of women age 65 years or older. You and your health care provider should talk regularly about whether you still need treatment with PREMARIN Vaginal Cream.
SOURCE Wyeth Pharmaceuticals