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FDA Approves Intrarosa for Treatment of Dyspareunia

FDA news release; 2016 Nov 17

The FDA has approved Intrarosa (prasterone), from Endoceutics Inc., to treat postmenopausal women experiencing pain during sex.

Indication: Intrarosa is the first FDA approved product containing the active ingredient prasterone, also known as dehydroepiandrosterone (DHEA), indicated to treat women experiencing moderate to severe pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA), due to menopause.

Dosage and administration: Intrarosa is a once-daily vaginal insert for postmenopausal women experiencing pain during sex.

Efficacy and safety: The efficacy of Intrarosa was established in two, 12-week placebo-controlled clinical trials of 406 healthy postmenopausal women, aged 40 to 80 years, who identified moderate to severe pain during sexual intercourse as their bothersome symptom of VVA. Women were randomly assigned to receive Intrarosa or a placebo vaginal insert. Intrarosa, when compared to placebo, was shown to reduce the severity of pain experienced during sexual intercourse. The safety of Intrarosa was established in four, 12-week placebo-controlled trials and one, 52-week open-label trial.

Adverse reactions: The most common adverse reactions with Intrarosa were vaginal discharge and abnormal Pap smear.

Citation:

US Food and Drug Administration. FDA approves Intrarosa for postmenopausal women experiencing pain during sex. FDA web site. November 17, 2016. http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm529641.htm. Accessed November 17, 2016.