FDA Approves Treatment for Menopause Associated Dyspareunia

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Intrarosa contains prasterone, an inactive precursor that is converted locally into estrogens and androgens to help restore vaginal tissue.
Intrarosa contains prasterone, an inactive precursor that is converted locally into estrogens and androgens to help restore vaginal tissue.

AMAG has announced the availability of Intrarosa (prasterone), the first Food and Drug Administration (FDA) approved local, non-estrogen product for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause.

Intrarosa contains prasterone, an inactive precursor that is converted locally into estrogens and androgens (with minimal systemic exposure) to help restore vaginal tissue. 

Intrarosa is contraindicated in patients with undiagnosed abnormal genital bleeding. Postmenopausal women with undiagnosed, persistent or recurring genital bleeding should be evaluated to determine the cause of the bleeding before considering treatment. In addition, vaginal discharge and abnormal pap smear findings have been associated with use of Intrarosa.

Intrarosa is supplied a vaginal insert containing 6.5mg of prasterone. Each box of Intrarosa contains 28 vaginal inserts with 28 applicators. 

Reference

FDA approves Intrarosa for postmenopausal women experiencing pain during sex [press release]. Silver Spring, MD: FDA. https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm529641.htm. Published November 17, 2016. Accessed August 28, 2017. 



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