Dyspareunia, severe pain during sexual intercourse, is a condition associated with declining levels of estrogen hormones during menopause. Less estrogen can make vaginal tissues thinner resulting in pain during sexual intercourse.
"Dyspareunia is among the problems most frequently reported by postmenopausal women," Dr. Victoria Kusiak, deputy director of the Office of Drug Evaluation III in the FDA's Center for Drug Evaluation and Research, said in a statement. "Osphena provides an additional treatment option for women seeking relief."
The drug was tested in three clinical studies of 1,889 postmenopausal women with symptoms of dyspareunia. Women were randomly assigned to receive Osphena or a placebo. After 12 weeks of treatment, results from the first two trials showed a statistically significant improvement of dyspareunia in Osphena-treated women compared with women receiving placebo. Results from the third study support Osphena's long-term safety in treating dyspareunia, the FDA said.
Osphena is being approved with a boxed warning alerting women and healthcare professionals the drug, which acts like estrogen on vaginal tissues and should they experience any unusual bleeding it may be a sign of endometrial cancer or a condition that can lead to this cancer, Kusiak said.
Osphena should be prescribed for the shortest duration consistent with treatment goals and risks for the individual woman, the FDA said.