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Menopause drug reaches goal in late-stage trial, says Wyeth

Wyeth Pharmaceuticals said that results were positive for its first phase III studies evaluating Pristiq for the treatment of moderate-to-severe vasomotor symptoms associated with menopause.

The studies showed that women who took Pristiq experienced a reduction in both the number and severity of hot flashes. Additional analyses 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.

Pristiq, a serotonin-norepinephrine reuptake inhibitor, is currently under review by the FDA and could be the first non-hormonal treatment for menopausal hot flashes and night sweats.

Joseph Camardo, senior vice president for Global Medical Affairs at Wyeth Pharmaceuticals, said: “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.”

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.