"Studies have shown that many women are not seeking treatment for VVA and 81% are unaware that VVA is a treatable medical condition and part of a constellation of symptoms associated with loss of estrogens," said Dr. Sheryl Kingsberg, President, North American Menopause Society. "I am delighted that our patients will now have a convenient treatment option with IMVEXXY and hope that the excitement generated by this new option will encourage women to talk to their healthcare provider and get relief from their pain and discomfort due to VVA." 

IMVEXXY For the Treatment of Moderate to Severe Dyspareunia Due to Menopause

Imvexxy's mechanism of action is the re-estrogenization of the tissue in and around the vagina. IMVEXXY's distinctive formulation ensures that it dissolves completely without mess, so patients can use it any time of day by placing the softgel capsule in the lower part of the vagina to treat the vulva and vagina. IMVEXXY is administered daily for two weeks followed by only twice a week dosing. Nine out of 10 patients who participated in a clinical trial reported that IMVEXXY was "easy to use."

The FDA approval of IMVEXXY is based on the results of a Phase , randomized, double-blind, placebo-controlled study that eva luated the safety and efficacy of IMVEXXY (4 mcg and 10 mcg) compared to placebo from baseline to week .
The study showed that IMVEXXY provided relief of moderate to severe dyspareunia due to menopause as early as week  for both doses.5 Statistically significant changes in vaginal cytology and pH were also observed.5 A substudy of the REJOICE trial eva luated the pharmacokinetics of IMVEXXY 4mcg, 10mcg, and placebo.
With both the 4 mcg and 10 mcg doses, the mean concentration of estradiol and estrone remained within average postmenopausal range.6 The results were published in the journal Menopause: The Journal of The North American Menopause Society.

The most common adverse reaction with IMVEXXY (incidence ≥3 percent) and greater than placebo was headache. There were no clinically significant differences in AEs observed between treatment and placebo groups.
Important safety information for IMVEXXY, including the boxed warning for endometrial cancer, cardiovascular disorders, breast cancer, and probable dementia, is provided below.
The full prescribing information may be viewed by visiting www.imvexxy.com. 

TherapeuticsMD anticipates that IMVEXXY will be available for commercial distribution in July. 

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