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
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: | October 4, 2018 | ||||
Time: | 4:45-5:00 pm | ||||
Title: |
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 | ||||
Time: | 4:15-4:30 pm | ||||
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 | ||||
Time: | 5:00-5:15 pm | ||||
Title: |
Evaluation of Systemic Effects of a Vaginal Estradiol Softgel Capsule (TX-004HR) in Menopausal Women with Moderate-to-Severe Dyspareunia |
||||
Posters |
|||||
Date: | October 4, 2018 | ||||
Time: | 6:00-7:00 pm | ||||
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 | ||||
About Imvexxy
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. |
Estrogen-Alone Therapy |
• 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 |
CONTRAINDICATIONS
- 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.
ADVERSE REACTIONS
- 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.
Forward-Looking Statements
This press release by
View source version on businesswire.com: https://www.businesswire.com/news/home/20180928005051/en/
Source:
TherapeuticsMD, Inc.
Investor Contact:
Nichol Ochsner,
561-961-1900, ext. 2088
Vice President Investor Relations
Nochsner@TherapeuticsMD.com