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updated 03:42, Sun October 07, 2007

Wyeth Reports Positive Data From Late-Stage Postmenopausal Studies, Plans NDA Submission

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COLLEGEVILLE, Pa. (AP) -- Drug developer Wyeth said Friday it plans to submit its new drug application to federal regulators for its postmenopausal drug and released positive late-stage data.

Wyeth Pharmaceuticals, a division of Wyeth, plans to file the application in the second quarter of 2008 to the U.S. Food and Drug Administration. The application is for its bazedoxifene drug paired with conjugated estrogens, or hormone therapy.

Bazedoxifene is an oral investigational drug for the treatment of hot flashes and vaginal dryness associated with menopause.

One Phase III study evaluated the effectiveness and safety of bazedoxifene with conjugated estrogens for treatment of menopausal vasomotor symptoms, also know as hot flashes and night sweats. The study showed that, when compared with placebo, bazedoxifene/conjugated estrogens "significantly reduced" the number and severity of hot flashes, the company said.

The most common side effects of the drug were headache and joint pain, according to the trial of 332 postmenopausal women with symptoms.

Data from another Phase III study looked at the effects of the same treatment on vulvar and vaginal atrophy, also called vaginal dryness, and sexual function in postmenopausal women. The company said the results were statistically significant for the relief of vulvar and vaginal atrophy symptoms.

The trial evaluated 601 postmenopausal women with moderate to severe vulvar and vaginal atrophy.

These data were presented at the North American Menopause Society Annual Meeting.

Shares of Wyeth rose $1.10, or 2.4 percent, to close at $47.69.

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