FDA approves Imvexxy for treatment of moderate-to-severe dyspareunia.- TherapeuticsMD.

TherapeuticsMD announced that the FDA has approved Imvexxy (estradiol vaginal inserts) for the treatment of moderate-to-severe dyspareunia (vaginal pain associated with sexual activity), a symptom of vulvar and vaginal atrophy (VVA), due to menopause. Imvexxy is the only product in its therapeutic class to offer a 4 mcg and 10 mcg dose, the 4 mcg representing the lowest approved dose of vaginal estradiol available.

The FDA approval of Imvexxy is based on the results of a Phase III, randomized, double-blind, placebo-controlled study that evaluated the safety and efficacy of Imvexxy (4 mcg and 10 mcg) compared to placebo from baseline to week 12. The study showed that Imvexxy provided relief of moderate to severe dyspareunia due to menopause as early as week 2 for both doses.5 Statistically significant changes in vaginal cytology and pH were also observed. A substudy of the REJOICE trial evaluated the pharmacokinetics of Imvexxy 4 mcg, 10 mcg, and placebo. With both the 4 mcg and 10 mcg doses, the mean concentration of estradiol and estrone remained within average postmenopausal range. The results were published in the journal Menopause: The Journal of The North American Menopause Society.

The most common adverse reaction with Imvexxy (incidence at least 3 percent) and greater than placebo was headache. There were no clinically significant differences in AEs observed between treatment and placebo groups.