WASHINGTON The Food and Drug Administration on Tuesday approved the first pill-based drug for women who experience pain during sex because of menopause.
The daily pill is called Osphena, and it is designed to treat menopausal symptoms that make the vaginal tissue thinner and more fragile, causing pain during sexual intercourse. The condition, known as dyspareunia, is one of the most commonly reported health ailments among postmenopausal women, according to the FDA. Menopause occurs when the ovaries stop producing the hormone estrogen, usually around age 45 or 50.
Osphena acts like replacement estrogen and makes vaginal tissue thicker and less fragile.
The drug carries a black box warning alerting doctors and patients that Osphena can increase the risk of endometrial cancer, stroke and blood clots. The drug's prescribing guidelines recommend that it be used for the shortest amount of time possible to achieve patients' treatment goals.
Common side effects of the drug include hot flashes, vaginal discharge, muscle spasms and excessive sweating.
The FDA approved the drug based on studies involving 1,889 postmenopausal women who were randomly assigned to receive Osphena or placebo. After 12 weeks, women taking the drug had a statistically significant improvement in their symptoms.
Osphena is made by Japanese pharmaceutical company Shionogi, which has U.S. operations in Florham Park, N.J.