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Study Evaluating Efficacy and Safety of Two Low-dose Regimens of PREMARIN Vaginal Cream for the Treatment of Moderate to Severe Vaginal Atrophy Now Published

COLLEGEVILLE, Pa., July 13 /PRNewswire-FirstCall/ -- Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), announced the publication of data that supported daily and twice-weekly use of PREMARIN((R)) (conjugated estrogens) Vaginal Cream 0.5 g to relieve some of the bothersome symptoms of moderate-to-severe vulvar and vaginal atrophy, including painful intercourse (dyspareunia). This study evaluated the efficacy of two low-dose regimens of conjugated estrogens (CE) cream (0.5 g daily and twice weekly) using a double-blind, placebo-controlled study design for 12 weeks followed by a 40-week open-label phase. Endometrial safety for both dosing regimens was also assessed in women who completed 52 weeks of therapy. These study results are published in the July/August issue of Menopause: The Journal of the North American Menopause Society.

In this study, dyspareunia was the most bothersome symptom at baseline (57%) followed by vaginal dryness, itching and burning.()Unlike hot flashes or night sweats, signs and symptoms of vaginal atrophy have been shown to increase over time in postmenopausal women.

"Based on market research data, we understand that many postmenopausal women are not discussing their symptoms with their health care professionals," says Gloria Bachmann, M.D., lead study author and 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. "We are encouraged by this 52-week data that showed twice-weekly use of PREMARIN Vaginal Cream was sufficient to provide relief from painful intercourse due to menopause. The study also supported daily use of PREMARIN Vaginal Cream 0.5 g to treat postmenopausal vaginal dryness. This information should aid postmenopausal women and their health care professionals in discussing whether and how they may treat vaginal atrophy."

Study Design and Results:

In this multicenter clinical study, 423 postmenopausal women (ages 45-80 years) with moderate-to-severe vaginal atrophy were randomized to receive PREMARIN Vaginal Cream 0.5 g (equivalent to a low-dose of CE cream 0.3 mg) or placebo once daily (21 days on/7 days off) or twice weekly for 12 weeks. Treatment regimens were consistent within the 12-week and 40-week periods. The primary endpoints of the study were changes in vaginal maturation index (VMI; percentage of superficial cells), vaginal pH and severity of participant-reported most bothersome symptom (vaginal dryness, itching, burning or dyspareunia) at week 12.()The study also evaluated safety related to systemic effects of CE cream on endometrial tissue during one year of therapy.

At week 12, improvements in VMI and vaginal pH with daily and twice-weekly use of PREMARIN Vaginal Cream 0.5 g were significantly greater relative to placebo (P<0.001). Results from the 12-week phase also showed that both low-dose regimens of PREMARIN Vaginal Cream (0.5 g daily and twice weekly) significantly improved the most bothersome symptoms score versus placebo at 12 weeks (P less than or equal to 0.001), including those for dyspareunia (P less than or equal to 0.01).

After 52 weeks of therapy, with the same respective dosing regimens as in the double-blind phase, results were similar to those observed at week 12 and demonstrated the efficacy of PREMARIN Vaginal Cream versus placebo. 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. In this study, the most common treatment emergent AE's were headache, infection, arthralgia and vaginitis.

About PREMARIN Vaginal Cream

PREMARIN Vaginal Cream is used to treat menopausal changes in and around the vagina and painful intercourse caused by these changes.()Menopause can cause changes in the vaginal tissue, resulting in uncomfortable symptoms. PREMARIN Vaginal Cream treats the underlying cause of many of these symptoms and can restore the tissues that provide elasticity and lubrication with a low-dose and low-cream volume. PREMARIN Vaginal Cream is only available by prescription.

Important Safety Information:

What is the most important information you should know about PREMARIN Vaginal Cream (an estrogen mixture)?

Estrogens may increase the chance 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 professional should check any unusual vaginal bleeding to find out 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 chance of getting heart attacks, strokes, breast cancer, and blood clots. Using estrogens, with or without progestins, may increase your chance of getting dementia, based on a study of women age 65 years or older. You and your health care professional should talk regularly about whether you still need treatment with PREMARIN Vaginal Cream.

PREMARIN((R) )(conjugated estrogens) 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 include headache, infection, abdominal pain, accidental injury, and vaginitis.

About Vulvar and Vaginal Atrophy

Women produce less estrogen after menopause. When estrogen levels begin dropping, vaginal walls become thinner and less lubricated, and some women experience vulvar and vaginal atrophy. Vulvar and vaginal atrophy can result in vaginal irritation, dryness, dyspareunia (painful sexual intercourse), discharge and bleeding after sex.

About Dyspareunia

Dyspareunia, or pain experienced during sexual intercourse, can be a bothersome symptom of vulvar and vaginal atrophy. Based on a survey of 200 women transitioning through menopause, approximately one in three reported experiencing dyspareunia. Dyspareunia typically does not subside without treatment.

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.

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, among others, risks related to our proposed merger with Pfizer, including satisfaction of the conditions of the proposed merger on the proposed timeframe or at all, contractual restrictions on the conduct of our business included in the merger agreement, and the potential for loss of key personnel, disruption in key business activities or any impact on our relationships with third parties as a result of the announcement of the proposed merger; 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; the outcome of government investigations; 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; global economic conditions; interest and currency exchange rate fluctuations and volatility in the credit and financial markets; 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, 2008, which was filed with the Securities and Exchange Commission on February 27, 2009. 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.

SOURCE Wyeth Pharmaceuticals
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