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THERAPEUTICSMD, INC. ANNOUNCES FDA APPROVAL OF TX-004HR: IMVEXXY

BOCA RATON, Fla.–(BUSINESS WIRE)–May 30, 2018– TherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative Palm Beach County based women’s healthcare company, today announced that the United States Food and Drug Administration (FDA) has approved IMVEXXY (estradiol vaginal inserts) for the treatment of moderate-to-severe dyspareunia (vaginal pain associated with sexual activity), a symptom of vulvar and vaginal atrophy (VVA), due to menopause. IMVEXXY is the only product in its therapeutic class to offer a 4 mcg and 10 mcg dose, the 4 mcg representing the lowest approved dose of vaginal estradiol available.  “IMVEXXY is a drug which was conceived, formulated, developed, and now approved in Palm Beach County, a clear demonstration of our life sciences cluster’s resources to bring a product from bench to bedside,” said Kelly Smallridge, President of the Business Development Board.

“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,” said Brian Bernick, MD, Chief Clinical Officer of TherapeuticsMD.  “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.”

“We are excited to bring IMVEXXY to market as TherapeuticsMD’s first FDA-approved drug as we strive to be the premier Women’s Health Company,” said Robert Finizio, Chief Executive Officer of TherapeuticsMD. “IMVEXXY reflects our long-standing corporate mission and commitment to health solutions that women want, based on the concepts of medical need, efficacy           y, safety, simplicity, and affordability. IMVEXXY will be offered at a price in parity with other products that have been on the market for 10 to 30 years. By ensuring patients can access IMVEXXY at an affordable price, TherapeuticsMD is doing the right thing for women.”

About Dyspareunia and Vulvar and Vaginal Atrophy (VVA)

VVA is a component of genitourinary syndrome of menopause (GSM), which may include, but is not limited to, genital symptoms of dryness, burning and irritation, sexual symptoms such as decreased lubrication, discomfort, and pain, and urinary symptoms such as urgency, dysuria, and recurrent urinary tract infections.  VVA is a chronic, progressive condition that leads to distressing symptoms and can progressively worsen if not treated.

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. Insufficient estrogen can also decrease vaginal fluids, change the acid balance of the vagina, and weaken pelvic floor muscles. All these factors can lead to dyspareunia.

VVA affects an estimated 32 million postmenopausal women in the US. Only about seven percent (2.3 million) of these women receive prescription treatment.3 Nearly 1 out of 2 women will experience pain during intercourse due to VVA at some point during their lives.3

“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 3, randomized, double-blind, placebo-controlled study that evaluated the safety and efficacy of IMVEXXY (4 mcg and 10 mcg) 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.5 Statistically significant changes in vaginal cytology and pH were also observed.5 A substudy of the REJOICE trial evaluated the pharmacokinetics of IMVEXXY 4 mcg, 10 mcg, 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.5 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.

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http://ir.therapeuticsmd.com/news-releases/news-release-details/therapeuticsmd-announces-fda-approval-tx-004hr-imvexxy-estradiol