Study Data Results Showed Desvenlafaxine Significantly Reduced Moderate to Severe Vasomotor Symptoms in Menopausal Women Vers... (eting represents only a portion of the t...)

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Study Data Results Showed Desvenlafaxine Significantly Reduced Moderate to Severe Vasomotor Symptoms in Menopausal Women Versus Placebo

Date:10/15/2007

eting 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 Asso
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Study Data Results Showed Desvenlafaxine Significantly Reduced Moderate to Severe Vasomotor Symptoms in Menopausal Women Vers...(eting represents only a portion of the t...)