Shionogi Inc.'s Osphena has been approved by FDA for postmenopausal women experiencing pain during sex, a condition known as dyspareunia.
Osphena is an estrogen agonist/antagonist, and becomes the first and only oral treatment alternative to vaginal or oral steroidal estrogens for women with dyspareunia due to menopause, said the company.
Available in pill form, Osphena, which is prescribed to be taken with food once daily, will sport a boxed warning.
The boxed warning alerts women about the risks of endometrial cancer, thrombotic and hemorrhagic strokes and deep vein thrombosis.
The FDA in a statement said that Osphena should be prescribed for the shortest duration consistent with treatment goals and risks for the individual woman.
Commenting on the approval, Victoria Kusiak, deputy director of the Office of Drug Evaluation III in the FDA's Center for Drug Evaluation and Research, said, "Dyspareunia is among the problems most frequently reported by postmenopausal women. Osphena provides an additional treatment option for women seeking relief."
Shionogi Inc. is the U.S.-based group company of Shionogi & Co., Ltd., a Japanese pharmaceutical company.
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