Is it Viagra for women, or Hormone Replacement Therapy by another name?
Osphena is coming to market soon and is claiming to be the solution to painful post-menopausal sex. But what are the downsides?
Will This Pill Fix Your Sex Life? - Newsweek and The Daily Beast
If even a fraction of those women are interested, the drug’s approval could be the start of a long-awaited dream for the pharmaceutical industry, which has labored for decades to define a catchall disorder of women’s sexuality and then develop a series of drugs to help. It’s been a fraught process, in which pharma has been accused of inflating numbers and has failed time and again to satisfy drug safety regulators at the FDA.
So it’s no wonder that some connected to the industry are crowing. Osphena “is a milestone in women’s menopause therapies,” says Margery Gass, a practicing gynecologist in Cleveland and executive director of the North American Menopause Society, which lists the drug’s manufacturer among its corporate liaison council. “It’s really good to have ... options for women at this point in life.”
But as the FDA allows Osphena (ospemifene) to head to market in June and Shionogi launches its “public education” campaign, starting with physicians, questions abound. First about whether this is a real disorder affecting a large percentage of American women. Second about how Osphena was approved. And third about whether Osphena, which mimics estrogen and has similar known downsides, may also be a back-door, off-label replacement for “hormone replacement therapy,” which was discredited a decade ago.