fda-approvals

Intrarosa Gets FDA Green Light

Intrarosa (prasterone) approved to treat painful sex due to menopause

By RxWiki Staff
November 21, 2016 · 1 min read
Intrarosa Gets FDA Green Light

The US Food and Drug Administration (FDA) has approved a new medication to treat women experiencing pain during intercourse. 

It's called Intrarosa (prasterone), and it's available as a vaginal insert that is applied once a day. The active ingredient, prasterone, is also known as dehydroepiandrosterone (DHEA).

This medication is approved particularly to treat women who have gone through menopause. That's because, during menopause, estrogen levels drop, particularly in the tissue in the vagina. As a result, women may experience VVA, a condition known as vulvar and vaginal atrophy. VVA can lead to pain during intercourse.

Prasterone received FDA approval after it appeared to reduce pain during intercourse in two clinical trials. 

The most common side effects included an abnormal Pap smear and vaginal discharge. 

Although some dietary supplements include DHEA, these products have not been tested for safety or effectiveness. Also, these products are not approved to diagnose, prevent, treat or cure any disease. 

Quebec-based Endoceutics Inc. is marketing Intrarosa.

Written by
RxWiki Staff
Editorial Team

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