Imvexxy Approved to Treat Dyspareunia
May 25, 2018 – The U.S. FDA has approved Imvexxy™ (estradiol vaginal inserts), manufactured by TherapeuticsMD, to treat moderate-to-severe dyspareunia (vaginal pain associated with sexual activity) due to menopause. Dyspareunia is a symptom of vulvar and vaginal atrophy (VVA).
Available in both a 4mcg and 10mcg dose, Imvexxy currently offers the lowest FDA-approved dose of vaginal estrogen available in the U.S. market. It is also the only such product designed to be applicator-free. According to a press release from the manufacturer, the product dissolves completely once applied, and can be used at any time of the day.
In clinical trials, Imvexxy produced pain relief as soon as the second week, and the mean concentration of estradiol and estrone in patients’ bodies remained within the average postmenopausal range.
Imvexxy, like other estrogen products, carries black box warnings that it may increase the risk of blood clots, strokes, dementia, breast cancer, or endometrial cancer when used either alone or with progestin therapy.
TherapeuticsMD plans to launch Imvexxy in July 2018.
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