TherapeuticsMD announced it has received FDA approval for IMVEXXY (estradiol vaginal inserts) for the treatment of moderate-to-severe dyspareunia.
TherapeuticsMD announced it has received FDA approval for estradiol vaginal inserts (Imvexxy) designed for the treatment of moderate-to-severe dyspareunia. According to the company, these inserts are the only product in their therapeutic class to offer 4 mcg and 10 mcg doses, the 4 mcg representing the lowest approved dose of vaginal estradiol available.
The estradiol vaginal inserts are used to treat vaginal pain associated with sexual activity, which is a symptom of vulvar and vaginal atrophy (VVA), due to menopause. The drug is expected to be made available to consumers in July, according to the company.
“Imvexxy is a bioidentical vaginal estrogen product that offers a fraction of the estrogen contained in the average doses of many existing products currently on the market,” said Brian Bernick, MD, Chief Clinical Officer of TherapeuticsMD, in a press release. He added it is the only product designed to be applicator-free, and dissolves completely. "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.”
VVA is a condition that develops when the body makes less estrogen due to menopause. Without sufficient estrogen, the vaginal tissue becomes thin, dry, and less elastic. The vaginal canal can also narrow and shorten. VVA is a chronic, progressive condition that leads to distressing symptoms and can progressively worsen if not treated.
VVA affects an estimated 32 million postmenopausal women in the United States. Approximately 7% (2.3 million) of these women receive prescription treatment. In addition, nearly 1 out of 2 women will experience pain during intercourse due to VVA at some point during their lives.
“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, in a statement issued by TherapeuticsMD.
The FDA approval of the product is based on the results of a phase 3, randomized, double-blind, placebo-controlled study that evaluated safety and efficacy compared to placebo from baseline to week 12. The study showed 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 also observed. A substudy, whose results were published in Menopause: The Journal of The North American Menopause Society, evaluated the pharmacokinetics of the 4 mcg and 10 mcg doses, and placebo. With both the 4 mcg and 10 mcg doses, the mean concentration of estradiol and estrone remained within average postmenopausal range.
The most common adverse effect (incidence ≥3%) and greater than placebo was headache. There were no clinically significant differences in adverse effects observed between treatment and placebo groups. There also is a boxed warning for endometrial cancer, cardiovascular disorders, breast cancer, and probable dementia.