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FDA Approves Osphena for Dyspareunia Post-Menopause

Once-daily pill carries boxed warning regarding risk of unusual endometrial bleeding, stroke, DVT

WEDNESDAY, Feb. 27 (HealthDay News) -- The U.S. Food and Drug Administration has approved the once-daily pill Osphena (ospemifene) to treat postmenopausal women experiencing moderate-to-severe pain during sexual intercourse.

The FDA approval was based on data from three randomized clinical studies, involving 1,889 postmenopausal women with symptoms of vulvar or vaginal atrophy. After 12-weeks of treatment, there was a significant improvement of dyspareunia for women treated with Osphena versus placebo in two of the trials. The long-term safety of Osphena was supported by the third trial.

Osphena includes a boxed warning notifying women and health care professionals that the drug can stimulate the endometrium and cause it to thicken. Unusual bleeding could be a sign of endometrial cancer or a condition that could lead to it and women who experience such bleeding should see their health care professional. Prescription of Osphena should be limited to the shortest duration consistent with individual treatment goals and risks. The boxed warning also reports the incidence rates of thrombotic strokes, hemorrhagic strokes, and deep vein thrombosis (0.72, 1.45, and 1.45 per 1,000 women, respectively). Other common side effects include hot flashes, vaginal and genital discharge, muscle spasms, and excessive sweating.

Osphena is marketed by Shionogi Inc., based in Florham Park, N.J.

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