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FDA approves a pill for post-menopausal sex problems

February 26, 2013|By Melissa Healy

It's not the pink Viagra many women have been waiting for, but a pill approved by the Food and Drug Administration on Tuesday aims to help women who have passed through menopause with a distinctly libido-killing problem: painful sex.

The FDA has approved a pill, Osphena, meant to be taken daily by post-menopausal women experiencing dyspareunia, or pain during sexual intercourse. Taken once daily, Osphena helps strengthen and build vaginal tissues, which respond to decreases in estrogen after menopause by becoming thin and more fragile. For roughly 32 million women in the United States, the result is discomfort, pain and tearing during intercourse.

Lubricants are not very effective for such women. And while estrogen-based medications have long been available in topical cream, suppository and insertable ring form, the makers of Osphena say that the new medication offers what for many will be a more convenient remedy for dyspareunia, and one that is not estrogen-based.

Unlike those creams and dissolving rings, the medication in Osphena is selective estrogen receptor modulators, or SERMs, which binds to estrogen receptors and activates many of the mechanisms that have shut down with menopause.

Estrogen-based medications for dyspareunia are thought to raise systemic levels of the hormone in a woman's body only slightly, and there is no evidence that, like estrogen-only hormone replacement therapy, it raises breast cancer risk. But some women remain wary of taking them, said Dr. David J. Portman, director of the Columbus Center for Women's Health Research in Ohio, who conducted some of the early safety and effectiveness trials of Osphena.

Osphena's "unique profile," Portman added, makes it more acceptable to such women.

In clinical trials presented to the FDA, women who took Osphena for as long as 15 months had a slightly elevated rate of blood clots compared with a comparison group of women on placebo medication. Those trials delivered mixed results on whether the drug lowers or raises stroke risk, and the FDA said the medication had not been adequately studied in women with breast cancer, so it should not be used by women with a suspected breast cancer or history of breast cancer.

A spokeswoman for Shionogi Inc., the maker of Osphena, said the company expects to make the new medication available in the United States in June 2013, and said that the medication's price has not yet been set.

Portman said that when offered a convenient solution, patients suffering from dyspareunia are a "grateful treatment population" because their condition often goes undiscussed and unaddressed. "This is a big win for women," he added.


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