TherapeuticsMD, Inc. (NYSE MKT: TXMD), an innovative women’s healthcare company, today announced the schedule of nine posters and oral presentations at upcoming medical conferences related to Yuvvexy, the conditionally-approved trade name for TX-004HR, an investigational applicator-free vaginal estradiol softgel capsule in development for the treatment of moderate-to-severe vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA), due to menopause.
The presentations support the results from the Yuvvexy clinical development program and further identify women’s perceptions of VVA and current available treatment options. Additional data to be presented provide new insights about the lack of understanding of VVA as a serious medical condition. The posters and presentations will be made at annual meetings of the International Menopause Society (IMS) on September 28 - October 1 in Prague, Czech Republic, and the North American Menopause Society (NAMS) on October 5-8 in Orlando, Florida.
“These presentations reflect the breadth and depth of our Yuvvexy clinical program, including the previously-presented phase 3 Rejoice Trial data, as well as the need for improved understanding of VVA as a serious medical condition, its symptoms such as dyspareunia, and the available treatment options,” said TherapeuticsMD co-founder and Chief Clinical Officer Brian Bernick, M.D. “We look forward to our IMS and NAMS presentations regarding Yuvvexy and, if approved, establishing this innovative product as a highly differentiated new therapy designed to satisfy the unmet needs of menopausal women suffering from symptoms of VVA.”
The posters and presentations will be made available on the Investors & Media section of the company’s website at www.therapeuticsmd.com. Details include:
IMS Oral Presentations | |||
Title | The REJOICE Trial: A Phase 3 Randomized Controlled Trial Evaluating the Safety and Efficacy of a Novel Vaginal Estradiol Softgel Capsule for Symptomatic Vulvar and Vaginal Atrophy (VVA) | ||
Date/Time | Friday, September 30, 2:30 - 2:45 p.m. (Oral Presentation) | ||
| Title | TX-004HR Vaginal Estradiol Effectively Treats Vulvar and Vaginal Atrophy (VVA) with Negligible to Low Systemic Absorption of Estradiol | ||
Date/Time | Friday, September 30, 2:45 - 3:00 p.m. (Oral Presentation) | ||
| Title | Improvement in Postmenopausal Sexual Dysfunction with TX-004HR as Measured by FSFI | ||
Date/Time | Saturday, October 1, 10:15 - 10:30 a.m. (Oral Presentation) | ||
NAMS Oral Presentations and Posters | |||
| Title | TX-004HR Improves Vaginal Physiology and Dyspareunia with Negligible Systemic Absorption | ||
Date/Time | Thursday, October 6, 4:30 – 4:45 p.m. (Oral Presentation) | ||
Title | Significant Improvement in Vaginal Epithelium with TX-004HR in Postmenopausal Women with Moderate-to-Severe Dyspareunia Associated with Vulvar and Vaginal Atrophy (VVA) | ||
Date/Time | Thursday, October 6, 5:00 – 5:15 p.m. (Oral Presentation) | ||
Title | The Women’s EMPOWER Survey: Identifying Women’s Perceptions of Vulvar and Vaginal Atrophy (VVA) | ||
Date/Time | Thursday, October 6, 5:30 – 5:45 p.m. (Oral Presentation) | ||
Title | The Women’s EMPOWER Survey: Women’s Knowledge and Treatment of Vulvar and Vaginal Atrophy (VVA) Remains Low, Years after Previous Surveys | ||
Date/Time | Thursday, October 6, 6:00 – 7:00 p.m. (Poster Presentation) | ||
Title | The Effect of Body Position on the Pharmacokinetics of TX-004HR, Estradiol Vaginal Softgel Capsule | ||
Date/Time | Thursday, October 6, 6:00 – 7:00 p.m. (Poster Presentation) | ||
| Title | TX-004HR Provides Robust Efficacy for Symptomatic Postmenopausal Vulvar and Vaginal Atrophy (VVA) while Providing Negligible to Very Low Systemic Absorption of Estradiol: Results of Phase 2 and Phase 3 Trials | ||
Date/Time | Friday, October 7, 1:45-2:00 p.m. (Oral Presentation) | ||
About TherapeuticsMD, Inc.
TherapeuticsMD, Inc. is an innovative healthcare company focused on developing and commercializing products exclusively for women. With its SYMBODA™ technology for the solubilization of bio-identical female hormones, TherapeuticsMD is developing pharmaceutical products to enable delivery of bio-identical hormones through a variety of dosage forms and administration routes. The company’s clinical development pipeline includes two phase 3 products. The company also manufactures and distributes branded and generic prescription prenatal vitamins as well as over-the-counter vitamins under the vitaMedMD® and BocaGreenMD® brands. More information is available at the following websites: www.therapeuticsmd.com, www.vitamedmdrx.com and www.bocagreenmd.com.
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 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 FDA will approve the company’s new drug application for its TX-004HR product candidate and whether any such approval will occur by the PDUFA date; the length, cost and uncertain results of the company’s clinical trials; 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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Contacts:
Investors
David
DeLucia, 561-961-1900
Director of Investor Relations
David.DeLucia@TherapeuticsMD.com
