FDA approves estradiol vaginal inserts for dyspareunia*

The Food and Drug Administration on May 30 approved estradiol vaginal inserts (Imvexxy) for moderate to severe menopause-related dyspareunia, in a 4-mcg and 10-mcg dose. The 4-mcg dose is a lower dose than any currently available.

The hormone treatment is intended for dyspareunia resulting from menopausal vulvar and vaginal atrophy. The patient places a soft gel capsule in the lower part of the vagina, daily for 2 weeks, then at a reduced rate of twice per week. The capsule dissolves and reintroduces estrogen to the tissue.

The FDA’s approval, announced by the manufacturer, follows a phase 3 trial in which doses of 4 mcg, 10 mcg, and 25 mcg all showed significant improvement, compared with placebo, in the study’s four primary endpoints: change from baseline to week 12 in percentages of superficial and parabasal cells, vaginal pH, and severity of dyspareunia (Menopause. 2017 Apr;24[4]:409-16). 

The manufacturer of the product, TherapeuticsMD, has committed to conduct a postapproval observational study, as a condition of approval.

Estradiol comes with a boxed warning of risks of endometrial cancer, stroke, deep vein thrombosis, pulmonary embolism, myocardial infarction, breast cancer, and “probable dementia.” The most common adverse reaction to the estradiol vaginal inserts was headache.

Editor's Note: This article has been corrected to state that the 4-mcg dose showed significant improvement in severity of dyspareunia.

[email protected]

The Food and Drug Administration on May 30 approved estradiol vaginal inserts (Imvexxy) for moderate to severe menopause-related dyspareunia, in a 4-mcg and 10-mcg dose. The 4-mcg dose is a lower dose than any currently available.

The hormone treatment is intended for dyspareunia resulting from menopausal vulvar and vaginal atrophy. The patient places a soft gel capsule in the lower part of the vagina, daily for 2 weeks, then at a reduced rate of twice per week. The capsule dissolves and reintroduces estrogen to the tissue.

The FDA’s approval, announced by the manufacturer, follows a phase 3 trial in which doses of 4 mcg, 10 mcg, and 25 mcg all showed significant improvement, compared with placebo, in the study’s four primary endpoints: change from baseline to week 12 in percentages of superficial and parabasal cells, vaginal pH, and severity of dyspareunia (Menopause. 2017 Apr;24[4]:409-16). 

The manufacturer of the product, TherapeuticsMD, has committed to conduct a postapproval observational study, as a condition of approval.

Estradiol comes with a boxed warning of risks of endometrial cancer, stroke, deep vein thrombosis, pulmonary embolism, myocardial infarction, breast cancer, and “probable dementia.” The most common adverse reaction to the estradiol vaginal inserts was headache.

Editor's Note: This article has been corrected to state that the 4-mcg dose showed significant improvement in severity of dyspareunia.

[email protected]

The Food and Drug Administration on May 30 approved estradiol vaginal inserts (Imvexxy) for moderate to severe menopause-related dyspareunia, in a 4-mcg and 10-mcg dose. The 4-mcg dose is a lower dose than any currently available.

The hormone treatment is intended for dyspareunia resulting from menopausal vulvar and vaginal atrophy. The patient places a soft gel capsule in the lower part of the vagina, daily for 2 weeks, then at a reduced rate of twice per week. The capsule dissolves and reintroduces estrogen to the tissue.

The FDA’s approval, announced by the manufacturer, follows a phase 3 trial in which doses of 4 mcg, 10 mcg, and 25 mcg all showed significant improvement, compared with placebo, in the study’s four primary endpoints: change from baseline to week 12 in percentages of superficial and parabasal cells, vaginal pH, and severity of dyspareunia (Menopause. 2017 Apr;24[4]:409-16). 

The manufacturer of the product, TherapeuticsMD, has committed to conduct a postapproval observational study, as a condition of approval.

Estradiol comes with a boxed warning of risks of endometrial cancer, stroke, deep vein thrombosis, pulmonary embolism, myocardial infarction, breast cancer, and “probable dementia.” The most common adverse reaction to the estradiol vaginal inserts was headache.

Editor's Note: This article has been corrected to state that the 4-mcg dose showed significant improvement in severity of dyspareunia.

[email protected]