BOCA RATON, Fla.--(BUSINESS WIRE)--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.
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