Study Data Results Showed Desvenlafaxine Significantly ReducedModerate to Severe Vasomotor Symptoms in Menopausal Women VersusPlacebo
COLLEGEVILLE, Pa., October 15, 2007 /PRNewswire-FirstCall/ -- Wyeth Pharmaceuticals, a division of Wyeth , reported that new study data presented today at the 63rd Annual Meeting of the American Society for Reproductive Medicine (ASRM) showed that women who received 100 mg/day or 150 mg/day of desvenlafaxine, a serotonin and norepinephrine reuptake inhibitor (SNRI), experienced a significant reduction in moderate to severe vasomotor symptoms (VMS) (hot flashes and night sweats) associated with menopause over those taking placebo. This significant reduction was seen as early as week one.
The common adverse drug reactions (greater than or equal to five percent of either desvenlafaxine group) in this study were asthenia, hypertension, anorexia (loss of appetite), constipation, diarrhea, dry mouth, nausea, dizziness, insomnia, somnolence and mydriasis.
"There are more than 10 million menopausal women who experience moderate to severe hot flashes and night sweats. Only a small percentage of menopausal women use FDA-approved treatments, all of which are hormone-based," says Ginger Constantine, M.D., Vice President, Women's Health Care, Wyeth Pharmaceuticals. "Wyeth is committed to continuing to develop desvenlafaxine as a potential non-hormonal treatment option for women with moderate to severe vasomotor symptoms associated with menopause."
In July 2007, Wyeth received an approvable letter from the FDA for desvenlafaxine in the treatment of moderate to severe vasomotor symptoms associated with menopause. Wyeth is working with the FDA to address several items in the letter and to gain agreement on the design of one additional safety study. The efficacy and safety data for desvenlafaxine presented at the meeting represents only a portion of the totality of data that the Company has submitted to the FDA.
"Additional treatment options are important for the millions of U.S. women experiencing hot flashes and night sweats associated with menopause," says David F. Archer, lead investigator of the 12-week study and professor in the Department of Obstetrics and Gynecology, Eastern Virginia Medical School, Clinical Research Center, Norfolk, Virginia. "Vasomotor symptoms can be quite disruptive for women in performing their daily activities. The study findings presented show that desvenlafaxine significantly reduced the number of hot flashes in postmenopausal women, and thus, if approved, may be an important treatment option."
About the Posters
Below are summaries of three separate analyses of the 12-week, multicenter, randomized, double-blind, placebo-controlled study. Postmenopausal women (N=458) with 50 or more moderate to severe hot flashes per week received either desvenlafaxine 100 mg/day, 150 mg/day or placebo. In addition, also presented was a secondary analysis of a previously presented 52-week study with desvenlafaxine.
Poster 412: Archer D., et al. Desvenlafaxine Succinate Efficacy for the Relief of Vasomotor Symptoms Associated With Menopause: A Double-Blind, Placebo-Controlled Trial
The analysis of the 12-week trial showed that desvenlafaxine 100 mg significantly reduced the frequency of moderate to severe hot flashes by 65 percent from baseline to the end of the trial, compared to a 51 percent reduction for placebo. This reduction in frequency of hot flashes with desvenlafaxine 100 mg was seen beginning at week one. The severity of hot flashes also reduced significantly at all time points compared to placebo among postmenopausal women who received desvenlafaxine.
Poster 421: Farmer M., et al. Safety and Tolerability of Desvenlafaxine Succinate in a Double-Blind, Placebo-Controlled Trial for the Relief of Vasomotor Symptoms Associated With Menopause
The safety analysis of the 12-week study showed that desvenlafaxine was generally well tolerated when patients started with a lower dose (50 mg/day) and then titrated to 100 mg/day. Nausea was reported by 25 percent of postmenopausal women who received either dose of desvenlafaxine, compared to seven percent in those who received placebo. Overall, adverse events led to discontinuation from the study in 11 percent in the desvenlafaxine dose groups, compared to seven percent of those receiving placebo.
There were few clinically important laboratory and vital sign changes, with no significant differences among treatment groups. Discontinuation symptoms have been generally observed with SNRIs and selective serotonin reuptake inhibitors (SSRIs). In this study, discontinuation symptoms were reported by 51 percent of women taking desvenlafaxine vs. 38 percent with women taking placebo.
Poster 422: Archer D., et al. Desvenlafaxine Succinate, a Novel Serotonin and Norepinephrine Reuptake Inhibitor, Improves Mood and Menopausal Symptoms in Women With Hot Flushes Associated with Menopause
Results from this secondary analysis of the 12-week study showed that desvenlafaxine 100 mg or 150 mg improved total mood disturbance score as measured by the Profile of Mood States (POMS), and climacteric symptoms as measured by the Greene Climacteric Scale (GCS), in postmenopausal women with moderate to severe vasomotor symptoms. Mood and climacteric symptoms were assessed by POMS and GCS, respectively, at baseline and weeks 4 and 12.
Wyeth Pharmaceuticals is committed to improving the care of patients and understanding the clinical and safety information about its products. The clinical development program for desvenlafaxine involves thousands of subjects and represents a continued exploration of the molecule's potential utility in multiple conditions.
Antidepressants, including SSRIs and SNRIs, increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents and young adults in short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber.
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 and pipeline products (including desvenlafaxine); 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.
Posted: October 2007