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New Estradiol Vaginal Insert Product Available for Dyspareunia

Imvexxy 4 mcg dose represents the lowest dose currently available

A PPM Brief

TherapeuticsMD (Boca Raton, FL) recently announced1 the commercial availability of a lower dose Imvexxy (estradiol vaginal inserts, 4 mcg dose) in the US. Imvexxy 4 mcg is the lowest dose vaginal estrogen product approved by FDA for the treatment of moderate-to-severe dyspareunia (ie, vaginal pain associated with sexual activity), often associated with vulvar and vaginal atrophy (VVA), which may occur due to menopause. Imvexxy is the only product in its therapeutic class to offer a 4 mcg and 10 mcg dose.

For post-menopausal women with VVA, the product provides improvement in moderate-to-severe dyspareunia within 12 weeks (beginning as early as two weeks for some women). Imvexxy is administered daily for two weeks followed by twice-a-week dosing to maintain treatment. The company recommends that women begin treatment at the 4 mcg dose, and that clinicians consider the 10 mcg dose depending on the patient’s clinical response. A softgel, Imvexxy is inserted about two inches into the vagina to re-estrogenize the vaginal tissue.

Imvexxy 4 mcg dose represents the lowest dose currently availableSource: 123RF

“These two distinct doses meet the different needs of women and their healthcare providers,” said Robert Finizio, CEO of TherapeuticsMD. “Imvexxy was designed with clinical and physical attributes to help provide a positive user experience. Imvexxy dissolves completely within hours, so patients can use it any time of day.”

The risk for serious side effects of estrogen treatment depends on the dose and the length of time it is used, therefore, low-dose, 2 week estradiol inserts such as the 4mcg Imvexxy is recommended. Nausea, vomiting, bloating, diarrhea, breast tenderness, headache, and weight changes are common adverse effects of treatment.

Last updated on: October 15, 2018
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Vaginal Atrophy and Chronic Pain
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