Wyeth Presents Phase 3 Data for Pristiq, an Investigational Non-Hormonal Therapy for Menopausal Hot Flashes and Night Sweats

    COLLEGEVILLE, Pa., May 9 /PRNewswire-FirstCall/ -- Wyeth
 Pharmaceuticals, a division of Wyeth (NYSE:   WYE), presented results from
 the first Phase 3 studies evaluating Pristiq(TM) (desvenlafaxine) for the
 treatment of moderate-to-severe vasomotor symptoms (hot flashes and night
 sweats) associated with menopause. These studies showed that women who took
 Pristiq experienced a reduction in both the number and severity of hot
 flashes. Additional analyses presented demonstrated that Pristiq reduced
 the number of nighttime awakenings and mood disturbances in postmenopausal
 women with hot flashes and night sweats and did not have a negative effect
 on sexual function.
     The data were presented at the 55th Annual Meeting of the American
 College of Obstetricians and Gynecologists (ACOG) in San Diego. Pristiq is
 currently under review by the U.S. Food and Drug Administration (FDA) and
 could be the first non-hormonal treatment for menopausal hot flashes and
 night sweats.
     "Millions of women experience hot flashes and night sweats during
 menopause, but there are currently no effective non-hormonal treatment
 options approved by the FDA," says Joseph Camardo, M.D., Senior Vice
 President, Global Medical Affairs, Wyeth Pharmaceuticals. "The data
 indicate Pristiq has the potential to expand the range of effective
 treatment options by providing a non-hormonal choice for menopausal women
 with moderate-to-severe vasomotor symptoms."
     Evaluation of Safety and Efficacy
     Three studies presented examine the efficacy of Pristiq at various
 doses while also evaluating its safety and tolerability profile. The most
 common side effect in all three studies was nausea, which was generally
 mild to moderate, was dose-dependent, and resolved quickly, on average
 within three days.
     Efficacy and Safety of Desvenlafaxine Succinate for Treatment of
 Menopausal Vasomotor Symptoms
     This one-year, multicenter, randomized, double-blind,
 placebo-controlled trial evaluated the safety and efficacy of Pristiq at
 multiple doses. The study included 689 postmenopausal women with 50 or more
 moderate-to-severe hot flashes per week. Primary endpoints were assessed at
 weeks four and 12 and included the daily number and severity of hot flashes
 and night sweats.
     Results from this study showed a reduction in the number and severity
 of hot flashes and night sweats at weeks four and 12 for several of the
 doses investigated. There was a rapid onset of action - within one week of
 starting therapy.
     Efficacy of Desvenlafaxine Succinate in the Treatment of Menopausal
 Vasomotor Symptoms
     This six month multicenter, randomized, double-blind,
 placebo-controlled trial evaluated the efficacy and safety of Pristiq. The
 study included 541 postmenopausal women with 50 or more moderate-to-severe
 hot flashes per week. Primary endpoints were assessed at weeks four and 12,
 and included the daily number and severity of hot flashes and night sweats.
     Pristiq demonstrated significant improvements compared with placebo for
 all primary endpoints. A statistically significant reduction in the number
 of hot flashes (60 to 66 percent) was maintained throughout the 26-week
 study period.
     A Placebo-Controlled Trial of Desvenlafaxine Succinate and Tibolone for
 Menopausal Vasomotor Symptoms
     This 12-week, multicenter, randomized, double-blind, placebo- and
 active-controlled trial evaluated the safety and efficacy of Pristiq. The
 study included 451 postmenopausal women with 50 or more moderate-to-severe
 hot flashes per week, in multiple countries outside of the United States.
     Results showed that at weeks four and 12, all groups experienced a
 decrease in the number and severity of hot flashes from baseline. There was
 no statistically significant difference between Pristiq and placebo;
 whereas, the difference between active comparator and placebo was
 significant.
     Additional Analyses
     Additional analyses of key secondary endpoints from these three studies
 were also presented.
     Effects of Desvenlafaxine on Sleep and Mood in Menopausal Women: A
 Pooled Analysis
     This pooled analysis of two studies (Efficacy and Safety of
 Desvenlafaxine Succinate for Treatment of Menopausal Vasomotor Symptoms and
 Efficacy of Desvenlafaxine Succinate in the Treatment of Menopausal
 Vasomotor Symptoms) showed that Pristiq reduced the number of nighttime
 awakenings, increased the number of average minutes slept, and improved the
 quality of sleep score, compared with placebo. In addition, at the doses
 studied, Pristiq showed greater improvements from baseline in the Profile
 of Mood States (POMS) total mood score compared with placebo, with
 significant improvements in four out of six domains.
     Sexual Function in Women Treated with Desvenlafaxine Succinate for
 Menopausal Vasomotor Symptoms
     This secondary analysis of the 52-week trial (Efficacy and Safety of
 Desvenlafaxine Succinate for Treatment of Menopausal Vasomotor Symptoms)
 previously described showed that at week 12, women taking Pristiq did not
 experience a significant decrease in sexual function. This was measured by
 the Sex Effects Scale (Sex FX), a questionnaire developed to evaluate
 states and changes in sexual function in subjects taking antidepressant
 medications. Overall, there was a low incidence of sexual adverse events,
 and there was no statistical difference between Pristiq and placebo.
     About Pristiq
     Pristiq is a serotonin-norepinephrine reuptake inhibitor (SNRI) being
 studied by Wyeth as a potential treatment for multiple indications,
 including moderate-to-severe menopausal hot flashes and night sweats.
 Pristiq is believed to work by affecting the balance of serotonin and
 norepinephrine. These chemicals, known as neurotransmitters, are thought to
 play an important role in the brain to regulate body temperature and,
 during menopause may become imbalanced leading to hot flashes and night
 sweats.
     Wyeth filed a New Drug Application June 23, 2006, with the FDA for
 Pristiq for the treatment of moderate-to-severe vasomotor symptoms
 associated with menopause. If approved, Wyeth anticipates that Pristiq will
 be the first and only non-hormonal medication indicated for the treatment
 of moderate-to-severe vasomotor symptoms associated with menopause in the
 United States. Based on review of publicly disclosed studies, Pristiq is
 the first non-hormonal therapy to be studied in long-term (six and 12
 months), placebo-controlled trials. Pristiq is also under review for the
 treatment of major depressive disorder, and Wyeth received an approvable
 letter from the FDA on January 23, 2007, for this indication.
     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.
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SOURCE Wyeth Pharmaceuticals