BOCA RATON, Fla.--(BUSINESS WIRE)--
TherapeuticsMD, Inc. (TXMD), an innovative women’s healthcare company, today announced the schedule of ten oral presentations and posters at NAMS 2018, the annual meeting of the North American Menopause Society being held in San Diego, California on October 3-6, 2018, related to ImvexxyTM (estradiol vaginal inserts) and TX-001HR, the Company’s investigational bio-identical hormone therapy combination of estradiol and progesterone in a single, oral softgel for the treatment of moderate-to-severe vasomotor symptoms due to menopause.
There will be three oral presentations reviewing the findings of the Phase 3 Replenish Trial of TX-001HR and the systemic profile of Imvexxy (TX-004HR).
“We are pleased to present additional data from the Replenish Trial that further support the safety and efficacy of TX-001HR as the first bio-identical combination hormone therapy of estradiol and progesterone,” said TherapeuticsMD Chief Medical Officer Sebastian Mirkin, M.D. “The FDA PDUFA target action date for TX-001HR is October 28, 2018. If approved, TX-001HR would provide an FDA-approved treatment option for the millions of postmenopausal women who are currently seeking treatment for moderate to severe vasomotor symptoms using unapproved compounded hormones.”
The posters and presentations will be made available on the Investors & Media section of the company’s website at www.therapeuticsmd.com.
|Date:||October 4, 2018|
Effects of Single-Capsule 17β-Estradiol/Progesterone (TX-001HR) on Metabolic Parameters and Cardiovascular Outcomes in Menopausal Women of the REPLENISH Trial
|Date:||October 5, 2018|
|Title:||17β-Estradiol/Progesterone in a Single, Oral, Softgel Capsule (TX-001HR) Significantly Increased the Number of Symptom-free Days in the REPLENISH Trial|
|Date:||October 5, 2018|
Evaluation of Systemic Effects of a Vaginal Estradiol Softgel Capsule (TX-004HR) in Menopausal Women with Moderate-to-Severe Dyspareunia
|Date:||October 4, 2018|
|Title:||Physical Characteristics of TX-004HR: An Ultra-Low-Dose (4- and 10-µg) Estradiol Softgel Capsule Vaginal Insert|
|Title:||A 17β-Estradiol, Softgel, Vaginal Capsule (TX-004HR) Demonstrated an Early Onset of Action for Treating Vulvar and Vaginal Atrophy (VVA) and Moderate-to-Severe Dyspareunia|
|Title:||Systemic Estradiol Levels with Low-Dose Vaginal Estrogens May Differ by Dose and by Product|
|Title:||Correlations of Serum Estradiol and Estrone Concentrations with Menopausal Outcomes and Bleeding|
|Title:||Effects of Single-Capsule 17β-Estradiol/Progesterone (TX-001HR) on Weight and Blood Pressure in Menopausal Women of the REPLENISH Trial|
|Title:||Estradiol and Progesterone Bioavailability for Moderate-to-Severe Vasomotor Symptom Treatment and Endometrial Protection with the Continuous-Combined Regimen of TX-001HR (Oral Estradiol and Micronized Progesterone Capsules)|
|Title:||TX-001HR is Associated with a Clinically Meaningful Effect on Severity of Moderate-to-Severe Vasomotor Symptoms in the REPLENISH Trial|
Imvexxy (estradiol vaginal inserts) is approved in the U.S. 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 dose representing the lowest approved dose of vaginal estradiol available. The full prescribing information may be viewed by visiting www.Imvexxy.com.
IMPORTANT SAFETY INFORMATION FOR IMVEXXY
|WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER and PROBABLE DEMENTIA|
See full prescribing information for complete boxed warning.
• There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens
• Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia
• The Women’s Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT)
• The WHI Memory Study (WHIMS) estrogen-alone ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older
Estrogen Plus Progestin Therapy
• Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia
• The WHI estrogen plus progestin substudy reported increased risks of stroke, DVT, pulmonary embolism (PE) and myocardial infarction (MI)
• The WHI estrogen plus progestin substudy reported increased risks of invasive breast cancer
• The WHIMS estrogen plus progestin ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older
- Imvexxy™ is contraindicated in women with any of the following conditions: undiagnosed abnormal genital bleeding; known, suspected, or history of breast cancer; known or suspected estrogen-dependent neoplasia; active DVT, PE, or history of these conditions; active arterial thromboembolic disease or a history of these conditions; known anaphylactic reaction or angioedema to Imvexxy; known liver impairment or disease; known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders.
WARNINGS AND PRECAUTIONS
- Imvexxy is intended only for vaginal administration. Systemic absorption may occur with the use of Imvexxy.
- The use of estrogen-alone and estrogen plus progestin therapy has been reported to result in an increase in abnormal mammograms requiring further evaluation.
- The WHI estrogen plus progestin substudy reported a statistically non-significant increased risk of ovarian cancer. A meta-analysis of 17 prospective and 35 retrospective epidemiology studies found that women who used hormonal therapy for menopausal symptoms had an increased risk for ovarian cancer. The exact duration of hormone therapy use associated with an increased risk of ovarian cancer, however, is unknown.
- Other warnings include: gallbladder disease; severe hypercalcemia, loss of vision, severe hypertriglyceridemia or cholestatic jaundice.
- Estrogen therapy may cause an exacerbation of asthma, diabetes mellitus, epilepsy, migraine, porphyria, systemic lupus erythematosus, and hepatic hemangiomas and should be used with caution in women with these conditions.
- Women on thyroid replacement therapy should have their thyroid function monitored.
- The most common adverse reaction with Imvexxy (incidence ≥ 3 percent) and greater than placebo was headache.
Please note that this information is not comprehensive. Please visit www.Imvexxy.com for the Full Prescribing Information, including the Boxed WARNING.
About TherapeuticsMD, Inc.
TherapeuticsMD, Inc. is an innovative 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.
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: whether the FDA will approve the NDA for the company’s TX-001HR product candidate and whether such approval will occur by the PDUFA target action date; the company’s ability to maintain or increase sales of its products; the company’s ability to develop and commercialize IMVEXXYTM, ANNOVERATM 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 agreement; 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 or adversely affect the commercialization of the company’s current or future approved products; 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.