Endoceutics NDA Approved for Women with Painful Intercourse

FDA has approved an Endoceutics NDA for Intrarosa (prasterone) to treat women experiencing moderate to severe pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA), due to menopause. Intrarosa is the first FDA-approved product containing the active ingredient prasterone, which is also known as dehydroepiandrosterone (DHEA). Although DHEA is included in some dietary supplements, those products have not been approved to treat or prevent any disease.

Approval was based on data from two 12-week placebo-controlled clinical trials of 406 healthy postmenopausal women, 40 to 80 years of age, who identified moderate to severe pain during sexual intercourse as their most bothersome symptom of VVA, an agency release says. (XXINSERT LINKXX). The most common adverse reactions were vaginal discharge and abnormal Pap smear.