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Menopause Drug in Final Testing Stages

-October 8, 2008

Wyeth, an American pharmaceutical company, is currently in the final stages of testing a new drug that would treat menopause symptoms. Known as Aprela, this new menopause medication has already proven effective in reducing hot flashes and helping women sleep better, two of the primary symptoms of menopause that women find most discomforting.

Aprela also has the added benefit of treating such menopause symptoms without causing breast tenderness or increasing women's risk of developing breast cancer. While breast tenderness is a common side effect of many current menopause medications, recent studies have found that such medications can also:

• Harden breast tissue
• Make mammograms harder to read
• Increase the chances that women will develop breast cancer

These health complications are due to the fact that current menopause medications are largely composed of estrogen or estrogen-progestin.

In contrast, Aprela combines estrogen with bazedoxifene, a drug classified as a "selective estrogen receptor modulator" (meaning that the drug can effectively block the effects of estrogen on certain cells).

Details of the Study
Although final stages of research are still underway, the results of earlier studies on Aprela were presented at the North American Menopause Society conference on October 9, 2008.

Early research included 3,400 women (at a median age of 57) who no longer menstruated and who also experienced typical menopause symptoms, including hot flashes and sleeping problems. The women were divided into three groups:

• One group received daily doses of Aprela for two years

• One group received Evista, a currently prescribed estrogen-progestin menopause medication

• One group received a placebo

The study found that women taking Aprela had less hot flashes and experienced better sleep without an increased incidence of breast cancer. However, because breast cancer can take up to a decade to develop, researchers are still tracking the long-term effects of Aprela as part of the final stages of their studies.

Wyeth expects to petition the FDA and other U.S. regulators to sell Aprela by the end of 2009.
(Source: CNN Health News)

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