TherapeuticsMD Announces Publication of Manuscript on the Women's Health Initiative Observational Study of Vaginal Estrogen Use in Postmenopausal Women

No significant difference in the risk of invasive breast cancer, stroke, colorectal cancer, endometrial cancer, and venous thromboembolism in vaginal estrogen users vs nonusers

Lower risk of cardiovascular disease, hip fracture, and all-cause mortality in vaginal estrogen users with an intact uterus vs nonusers with an intact uterus

TherapeuticsMD, Inc. (NYSE MKT: TXMD), an innovative women's healthcare company, today announced the publication of the manuscript detailing results of the Women's Health Initiative Observational Study of vaginal estrogen use in postmenopausal women in Menopause: The Journal of The North American Menopause Society, a widely-regarded forum for scholarly articles on the leading research related to menopause. The Women's Health Initiative Observational Study, conducted from 1993 to 2005, is an NIH-sponsored, observational study that enlisted 93,676 postmenopausal women between the ages of 50 to 79 to give reliable estimates of the extent to which known risk factors predict heart disease, cancers, and fractures.

The manuscript, titled "Breast cancer, endometrial cancer, and cardiovascular events in participants who used vaginal estrogen in the Women's Health Initiative Observational Study," represents the first, large prospective observational study that evaluates the overall health risks and benefits of vaginal estrogen therapy. The study demonstrated no significant difference in the risk of invasive breast cancer, stroke, colorectal cancer, endometrial cancer, and venous thromboembolism in vaginal estrogen users vs nonusers. The study also shows that, among women with an intact uterus, there was a decreased risk of cardiovascular disease, hip fracture, and all-cause mortality in vaginal estrogen users vs nonusers. The study evaluated over 4,000 women who used vaginal estrogens for a median duration of two to three years. The manuscript is available online in the journal Menopause.

"This is the first study identifying the real world use of vaginal estrogen and the associated risks and benefits. We believe that these data, which includes two to three years of median duration of use of vaginal estrogen products, should address the only approvability issue raised by the FDA for TX-004HR – the lack of long-term endometrial safety data beyond the 12 weeks studied in the REJOICE trial," said TherapeuticsMD Chief Medical Officer Sebastian Mirkin.

TherapeuticsMD intends to submit the manuscript to the New Drug Application (NDA) for TX-004HR, the company's investigational applicator-free estradiol vaginal softgel capsule for the treatment of moderate-to-severe vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA) due to menopause, as part of the Company's submission of additional endometrial safety information to the FDA on or before September 18, 2017.

"The recently published article in Menopause on vaginal estrogen and clinical outcomes, including cardiovascular disease and cancer, in the Women's Health Initiative Observational Study demonstrates no elevation in risk of these adverse outcomes among postmenopausal women using vaginal estrogen, providing further reassurance about the safety of treatment," said JoAnn Manson, MD, Professor of Medicine at Harvard Medical School and Brigham and Women's Hospital, past President of the North American Menopause Society, and coauthor of the new study published in Menopause. "This study adds to the totality of the scientific evidence that supports a distinction between low-dose vaginal and systemic estrogen products, including modifications in the labeling of low-dose vaginal estrogen products."

About Vulvar and Vaginal Atrophy (VVA)

An estimated 32 million women in the United States are currently suffering from symptoms of VVA, and only 2.3 million (7 percent) are currently being treated with prescription therapy. VVA symptoms can range from mild to severe and include dyspareunia, vaginal dryness, urinary tract infections, and vaginal bleeding associated with sexual activity. Vaginal dryness and dyspareunia are considered the most bothersome symptoms of VVA. Because of the chronic nature of VVA due to menopause, its symptoms will not likely resolve without intervention.

The burden of VVA in the United States may increase due to aging of the population. Furthermore, due to increasing longevity, women may now suffer from VVA or other conditions related to decreased reproductive hormone levels for over one-third of their lives.

About TherapeuticsMD, Inc.

TherapeuticsMD, Inc. is an innovative healthcare company focused on developing and commercializing products exclusively for women. With its SYMBODA™ technology, TherapeuticsMD is developing advanced hormone therapy pharmaceutical products to enable delivery of bio-identical hormones through a variety of dosage forms and administration routes. The company's late stage clinical pipeline includes two phase 3 product candidates: TX-001HR for treatment of moderate-to-severe vasomotor symptoms (VMS) due to menopause and TX-004HR for treatment of moderate-to-severe vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA) due to menopause. The company also manufactures and distributes branded and generic prescription prenatal vitamins under the vitaMedMD® and BocaGreenMD® brands.

Forward-Looking Statements

This press release by TherapeuticsMD, Inc. may contain forward-looking statements. Forward-looking statements may include, but are not limited to, statements relating to TherapeuticsMD's objectives, plans and strategies as well as statements, other than historical facts, that address activities, events or developments that the company intends, expects, projects, believes or anticipates will or may occur in the future. These statements are often characterized by terminology such as "believes," "hopes," "may," "anticipates," "should," "intends," "plans," "will," "expects," "estimates," "projects," "positioned," "strategy" and similar expressions and are based on assumptions and assessments made in light of management's experience and perception of historical trends, current conditions, expected future developments and other factors believed to be appropriate. Forward-looking statements in this press release are made as of the date of this press release, and the company undertakes no duty to update or revise any such statements, whether as a result of new information, future events or otherwise. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties, many of which are outside of the company's control. Important factors that could cause actual results, developments and business decisions to differ materially from forward-looking statements are described in the sections titled "Risk Factors" in the company's filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, as well as reports on Form 8-K, and include the following: the company's ability to resolve the deficiencies identified by the FDA in the company's new drug application for its TX-004HR product candidate and the time frame associated with such resolution; whether the company will be able to prepare an amended NDA for its TX-004HR product candidate and, if prepared, whether the FDA will accept and approve the NDA; the company's ability to maintain or increase sales of its products; the company's ability to develop and commercialize its hormone therapy drug candidates and obtain additional financing necessary therefor; whether the company will be able to prepare an NDA for its TX-001HR product candidate and, if prepared, whether the FDA will accept and approve the NDA; the length, cost and uncertain results of the company's clinical trials, including any additional clinical trials that the FDA may require in connection with TX-004HR; the potential of adverse side effects or other safety risks that could preclude the approval of the company's hormone therapy drug candidates; the company's reliance on third parties to conduct its clinical trials, research and development and manufacturing; the availability of reimbursement from government authorities and health insurance companies for the company's products; the impact of product liability lawsuits; the influence of extensive and costly government regulation; the volatility of the trading price of the company's common stock and the concentration of power in its stock ownership. PDF copies of the company's historical press releases and financial tables can be viewed and downloaded at its website: www.therapeuticsmd.com/pressreleases.aspx.

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