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FDA approves vaginal cream to treat painful sexual intercourse in postmenopausal women
November 13, 2008 - 4:46 p.m.

COLLEGEVILLE, Pa. (AP) - Wyeth said Thursday its hormone-replacing drug Premarin Vaginal Cream has been approved for a new use against pain experienced by postmenopausal women during sex.

Shares of the Madison, N.J.-based company rose $2.76, or 8.5 percent, to $35.20.

The drugmaker said the Food and Drug Administration cleared the cream-based product to treat dyspareunia, which causes deterioration of vaginal tissue in some elderly women.
Regulators approved the additional use based on a Wyeth study that patients taking Premarin Vaginal Cream had significantly improved dyspareunia symptoms compared with patients taking placebo.

The FDA also approved a less frequent, twice weekly dosing of the drug, which was originally approved in a daily, 21-day regimen.

Premarin is already available to treat symptoms of menopause, including hot flashes, night sweats and vaginal dryness.

Premarin and another Wyeth drug, Prempro, dominated the market for menopause symptom treatments until 2002, when a huge federal study linked long-term use to a slight increase in breast cancer and other health problems. The drugs triggered numerous lawsuits against Wyeth.
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