TherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative women’s healthcare company, today announced the schedule of two oral presentations and five posters that will be presented at the 2019 Annual Meeting of the North American Menopause Society (NAMS) being held on September 25-28, 2019, related to IMVEXXY® (estradiol vaginal inserts) and BIJUVA® (estradiol and progesterone capsules).
“We are excited to report results from the REPLENISH Phase 3 trial for BIJUVA that show improvements in several sleep parameters, including sleep disturbances, in menopausal women with moderate to severe vasomotor symptoms taking BIJUVA as compared to placebo. In addition, we will present data for BIJUVA showing a consistency of effect for improvements in the frequency and severity of vasomotor symptoms in different subpopulations, regardless of age or body mass index,” said TherapeuticsMD Chief Medical Officer Sebastian Mirkin, M.D.
Additionally, two oral presentations will review the growth of the vulvar vaginal atrophy (VVA) market and patient acceptability data, including patient satisfaction and preference, for IMVEXXY.
The posters and presentations will be made available on the Investors & Media section of the company’s website at www.therapeuticsmd.com.
Oral Presentations
Date: September 27, 2019
Time: 4:15 - 4:30 pm
Title: Growth of the Vulvar Vaginal Atrophy (VVA) Therapy Market
Date: September 27, 2019
Time: 4:30 - 4:45 pm
Title: Postmenopausal Women Using a Softgel Estradiol Vaginal Insert to Treat Moderate-to-Severe Dyspareunia were Satisfied with it and Preferred it over a Previous Therapy
Posters
Date: September 25, 2019
Time: 6:00 - 7:00 pm
Title: Uterine Bleeding Rates with Hormone Therapies in Menopausal Women with Vasomotor Symptoms (Poster P-55)
Title: Baseline Estradiol Levels in Postmenopausal Women (Poster P-11)
Title: Nonsmokers May Benefit from Lower Doses of an Oral 17β-Estradiol/Progesterone Capsule — Data from the REPLENISH Trial (Poster P-12)
Title: Oral 17β-Estradiol/Progesterone (E2/P4) Improved Sleep Outcomes in the REPLENISH Trial (Poster P-31)
Title: E2/P4 Capsules Effectively Treat Vasomotor Symptoms Irrespective of Age and BMI (Poster P-6)
Please see the Full Prescribing Information, including indication and Boxed WARNING, for IMVEXXY and BIJUVA as follows:
INDICATION
IMVEXXY (estradiol vaginal inserts) is an estrogen indicated for the treatment of moderate-to- severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause.
IMPORTANT SAFETY INFORMATION
WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER and PROBABLE DEMENTIA
See full prescribing information for complete boxed warning.
Estrogen-Alone Therapy
Estrogen Plus Progestin Therapy
CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
ADVERSE REACTIONS
Please note that this information is not comprehensive. Please see/click here for the Full Prescribing Information, including the Boxed Warning.
INDICATION
BIJUVA is a combination of estradiol and progesterone indicated in a woman with a uterus for the treatment of moderate to severe vasomotor symptoms due to menopause.
IMPORTANT SAFETY INFORMATION
WARNING: CARDIOVASCULAR DISORDERS, BREAST CANCER, ENDOMETRIAL CANCER, and PROBABLE DEMENTIA
See full prescribing information for complete boxed warning.
Estrogen Plus Progestin Therapy
Estrogen-Alone Therapy
CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
ADVERSE REACTIONS
The most common adverse reactions (≥3%) for BIJUVA are breast tenderness (10.4%), headache (3.4%), vaginal bleeding (3.4%), vaginal discharge (3.4%) and pelvic pain (3.1%).
Please note that this information is not comprehensive. Please see the Full Prescribing Information including BOXED WARNING at www.BIJUVA.com.
About TherapeuticsMD, Inc.
TherapeuticsMD, Inc. is an innovative, leading healthcare company, focused on developing and commercializing novel products exclusively for women. Our products are designed to address the unique changes and challenges women experience through the various stages of their lives with a therapeutic focus in family planning, reproductive health, and menopause management. The company is committed to advancing the health of women and championing awareness of their healthcare issues. To learn more about TherapeuticsMD, please visit www.therapeuticsmd.com or follow us on Twitter: @TherapeuticsMD and on Facebook: TherapeuticsMD.
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 IMVEXXY®, ANNOVERA™, BIJUVA® and its hormone therapy drug candidates and obtain additional financing necessary therefor; whether the company will be able to comply with the covenants and conditions under its term loan facility; the potential of adverse side effects or other safety risks that could adversely affect the commercialization of the company’s current or future approved products or preclude the approval of the company’s future drug candidates; the length, cost and uncertain results of future clinical trials; the company’s reliance on third parties to conduct its manufacturing, research and development and clinical trials; the ability of the company’s licensees to commercialize and distribute the company’s products; 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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Investor Contact
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561-961-1900, ext. 2088
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