Osphena (ospemifene), an oral therapy drug designed by Shionogi to reduce painful intercourse, a symptom of vulvar and vaginal atrophy (VVA), for postmenopausal women has been approved for the market by the FDA (February 27).
Osphena, a selective estrogen receptor modulator (SERM), is the first oral alternative to vaginal or oral estrogens approved in the U.S. to treat painful intercourse due to menopause, says Japan's Shionogi.
"Dyspareunia is among the problems most frequently reported by postmenopausal women," said Dr. Victoria Kusiak, the deputy director of the Office of Drug Evaluation III in the FDA's Center for Drug Evaluation and Research. "Osphena provides an additional treatment option for women seeking relief."
Two 12-week studies showed that those on the drug had significant improvements in dyspareunia compared with those on placebo. A third study vouched for its longer-term safety.
Risks of the drug include an increased risk of strokes and deep vein thrombosis. Common side effects include hot flashes, vaginal discharge, muscle spasms and excessive sweating.
by RTT Staff Writer
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