Wall Street Journal (01/31/12) Loftus, Peter
Pfizer intends to seek U.S. regulatory approval to sell a new menopause drug, Aprela, as an alternative to older hormone-replacement therapies. Olivier Brandicourt, president and general manager of Pfizer's primary-care unit, said that the drug could reduce menopausal symptoms, such as hot flashes, and may help prevent bone-thinning osteoporosis, all with an improved safety and tolerability profile. A decade ago, the Women's Health Initiative raised safety concerns about hormone-replacement therapies, prompting many women to stop using them. The new Aprela contains conjugated estrogens, an active ingredient found in the older drugs, but combines these conjugated estrogens with bazedoxifene, which could mitigate the risks. Bazedoxifene is a selective estrogen receptor modulator in the same category as Eli Lilly & Co.'s Evista, approved for the prevention and treatment of osteoporosis. While clinical trials have suggested that Aprela has a favorable tolerability profile, without the same safety concerns about long-term estrogen use, the drug's development has taken longer than expected. The FDA previously declined to approve stand-alone bazedoxifene without more information about the incidence of strokes and certain blood clots in clinical tests.

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