Wyeth’s new menopause pill, combining the hormone estrogen with a bone-loss remedy, reduced hot flas

Results of a 12-week study of the drug, called Aprela, were presented today at a medical meeting in Dallas. Wyeth, based in Madison, New Jersey, said in a statement today that it intends to file for U.S. marketing approval in the 2008 second quarter.

Wyeth’s director of women’s health, Ginger Constantine, said Aprela is a “major paradigm shift in menopause therapy” because it appears to curb hot flashes and strengthen bones without raising the risk of breast or uterine cancer. The company has projected Aprela sales of US$2 billion a year, offsetting a plunge in revenue from the hormones Premarin and Prempro after U.S. studies in 2002 linked the drugs to cancer and heart attacks.

“It’s the holy grail to find a drug that treats hot flashes as well as estrogen without the risks associated with hormone therapy,” said Michelle Warren, a professor of obstetrics and gynecology at Columbia University Medical Center in New York who wasn’t involved in the study, in a telephone interview. “If Aprela is as good as Wyeth says it is, and the data bears this out, I would use this drug as first-line therapy.”

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