FDA Approves TX-004HR Estradiol Vaginal Inserts for Treatment of Dyspareunia

IMVEXXY is the only product in its therapeutic class to offer a 4 mcg and 10 mcg dose.

The US Food and Drug Administration (FDA) approved TX-004HR estradiol vaginal inserts (IMVEXXY) for the treatment of moderate-to-severe dyspareunia, a symptom of vulvar and vaginal atrophy due to menopause, announced TherapeuticsMD.

This is the only approved product in its therapeutic class to offer a 4-mcg and 10-mcg dose—with the 4-mcg representing the lowest approved dose of vaginal estradiol available.

“IMVEXXY is a bio-identical vaginal estrogen product that offers a fraction of the estrogen contained in the average doses of many existing products currently on the market,” Brian Bernick, MD, chief clinical officer, TherapeuticsMD, said in a statement. “IMVEXXY is the only product specifically designed to be applicator-free. It dissolves completely without mess or additional clean-up, and can be used anytime of day. It allows women the freedom to immediately return to their normal daily activities. Studies showed that, in patients who used IMVEXXY, systemic absorption of estradiol remained within postmenopausal range.”

The approval is backed by results of a phase 3, randomized, double-blind, placebo-controlled study that evaluated the safety and efficacy of IMVEXXY 4 mcg and 10 mcg versus placebo from baseline to week 12.

Study results concluded that IMVEXXY provided relief of moderate to severe dyspareunia due to menopause as early as week 2 for both doses. Statistically significant changes in vaginal cytology and pH were observed.

Researchers conducted REJOICE, a substudy that evaluated the pharmacokinetics of IMVEXXY 4 mcg, 10 mcg and placebo that found both IMVEXXY doses maintained the mean concentration of estradiol and estrone within average postmenopausal range.

The most common adverse effects with an incidence ≥3% and greater than placebo was headache, and there were no clinically significant differences in adverse effects observed between treatment and placebo groups.

Nine out of 10 patients reported that IMVEXXY was easy to use.

IMVEXXY is administered daily for 2 weeks followed by only twice a week dosing.

As part of the FDA approval, TherapeuticsMD has committed to conduct a post-approval observational study.

It’s anticipated that IMVEXXY will be available for commercial distribution in July.