Drug contained in a once-daily insert
THURSDAY, Nov. 17, 2016 (HealthDay News) -- Intrarosa has been approved by the U.S. Food and Drug Administration to treat women who have moderate-to-severe pain during sexual intercourse caused by post-menopausal vulvar and vaginal atrophy (VVA).
As the FDA explained, during menopause estrogen levels can decline in vaginal tissues, leading to VVA.
The product, contained in a once-daily insert, is the first approved to include the active ingredient prasterone, also known as dehydroepiandrosterone (DHEA), the agency said Thursday in a news release.
The product's effectiveness was established in two 12-week clinical trials involving 406 post-menopausal women, aged 40 to 80. The most common adverse reactions included vaginal discharge and abnormal Pap smear, a test used to detect cervical cancer.
DHEA is contained in some dietary supplements, although the FDA said it hasn't evaluated the safety and effectiveness of such supplements.
Intrarosa is marketed by Endoceutics Inc., based in Quebec, Canada.
Visit the FDA to learn more.