Imvexxy (estradiol vaginal inserts) 4mcg has been made available by TherapeuticsMD for the treatment of moderate-to-severe dyspareunia due to menopause, representing the lowest approved dose of vaginal estradiol available. The treatment is also available in a 10mcg dosage strength which launched in August 2018.

According to the Imvexxy prescribing information, women should generally be started at the 4mcg dosage strength with dosage adjustment guided by clinical response. In a 12-week, Phase 3 study, both the 4mcg and 10mcg doses of Imvexxy led to relief of moderate to severe dyspareunia due to menopause as early as week 2.

As with other estrogen replacement therapies, the labeling for Imvexxy includes a Boxed Warning regarding the risk of endometrial cancer, cardiovascular disorders, breast cancer, and probable dementia. 

The softgel capsule is administered intravaginally without an applicator once daily for 2 weeks, followed by 1 insert twice weekly.

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