Federal regulators today approved a new drug to treat women experiencing pain during sex from menopause-related symptoms. The drug, called Osphena, is by Shionogi Inc., a Japanese pharmaceutical company whose U.S. headquarters is in Florham Park.
Osphena treats a condition known as dyspareunia, which is associated with declining levels of estrogen hormones during menopause, the U.S. Food and Drug Administration said today in announcing its decision.
Less estrogen can make vaginal tissues thinner, drier and more fragile, resulting in pain during sexual intercourse. It is among the problems most frequently reported by postmenopausal women, said Victoria Kusiak, deputy director of the FDA’s Center for Drug Evaluation and Research.
Common side effects reported during clinical trials include hot flashes, vaginal discharge, muscle spasms and excessive sweating, the FDA said.
Osphena will also come with a boxed warning alerting women and doctors that the drug may cause the uterus lining to thicken, which is not normal for postmenopausal women. The warning will also include the drug’s low risks of causing stroke and deep vein thrombosis.