Wyeth Hot Flashes Drug Succeeds in Trial-Research
COLLEGEVILLE, Pa., Oct. 5 -- Wyeth Pharmaceuticals, a division of Wyeth, presented new data today from two Phase 3 studies, which showed that bazedoxifene/conjugated estrogens reduced the number and severity of hot flashes in symptomatic postmenopausal women by up to 80 percent, when compared with placebo. These data, presented at the North American Menopause Society Annual Meeting, also showed that bazedoxifene/conjugated estrogens improved symptoms of vulvar and vaginal atrophy. In addition, secondary data from both studies showed that when compared with placebo, bazedoxifene/conjugated estrogens reduced sleep disturbances and improved menopause-related quality of life.
"The pairing of bazedoxifene, a selective estrogen receptor modulator, or SERM, with conjugated estrogens may lead to a new class of menopausal therapy called tissue selective estrogen complex, or TSEC," says Ginger Constantine, M.D., Vice President, Women's Health Care and Bone Repair, Wyeth Pharmaceuticals. "TSECs pair the benefits of estrogens with SERMs to create a distinct clinical profile, which may provide relief of hot flashes and vaginal dryness as well as bone and uterine protection."
Update on NDA Filing
Wyeth plans to submit its New Drug Application (NDA) to the U.S. Food and Drug Administration for bazedoxifene/conjugated estrogens in the second quarter of 2008 subject to the further analysis and successful completion of product formulation, bioequivalence and clinical studies, and other remaining work necessary to finalize the NDA.
Significant Reduction of Hot Flashes and Relief of Vulvar and Vaginal Atrophy Symptoms
Results of a clinical trial titled "A Phase 3 Study of the Efficacy and Safety of Bazedoxifene/Conjugated Estrogens for Treatment of Menopausal Vasomotor Symptoms," which evaluated 332 symptomatic postmenopausal women who, at baseline, experienced seven or more moderate to severe hot flashes per day or 50 or more hot flashes per week were presented. The study showed that, when compared with placebo, bazedoxifene/conjugated estrogens significantly reduced the number and severity of hot flashes. Furthermore, the incidences of breast pain and bleeding were less than 5 percent and did not differ from placebo. The most commonly reported adverse events were headache and joint pain.
Data from another Phase 3 study titled "Effects of the TSEC Bazedoxifene and Conjugated Estrogens on Vulvar/Vaginal Atrophy and Sexual Function in Postmenopausal Women," which evaluated 601 postmenopausal women with moderate to severe vulvar and vaginal atrophy, also were presented. These data showed that bazedoxifene/conjugated estrogens improved symptoms of vulvar and vaginal atrophy, including dryness. In addition, bazedoxifene/conjugated estrogens improved vaginal lubrication, sexual function and menopause-related quality of life, when compared with placebo. The incidences of breast pain and bleeding were less than 5 percent and did not differ from placebo. There were no differences among groups in the incidences of adverse events and discontinuation rates.
"Bazedoxifene/conjugated estrogens, if approved, will be a new and different therapeutic option that has the potential to change the way physicians and their patients treat menopausal symptoms and prevent postmenopausal osteoporosis," says Dr. Constantine.
The efficacy and safety data for bazedoxifene/conjugated estrogens presented at this meeting represents only a portion of the totality of data available at this time.
According to the U.S. Census Bureau, in 2006, there were approximately 20 million women of menopausal age (45-54 years) in the United States. As many as 50 percent to 90 percent of women going through menopause experience vasomotor symptoms, such as hot flashes, which can greatly impact a woman's life. Furthermore, between 10 percent and 40 percent of postmenopausal women experience symptoms of vulvar and vaginal atrophy, which typically do 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 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 based on current expectations of future events and 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 the inherent uncertainty of the timing and success of, and expense associated with, research, development, regulatory approval and commercialization of our products, including with respect to our pipeline products (including our planned submission of a New Drug Application for bazedoxifene/conjugated estrogens); government cost-containment initiatives; restrictions on third-party payments for our products; substantial competition in our industry, including from branded and generic products; data generated on our 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." 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.