-7 Presentations at the 16th
“The Imvexxy presentations highlight the importance of vaginal estrogen therapy as an effective treatment option for the millions of menopausal women suffering from moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy,” said
Please see Important Safety Information, including boxed warning, for Imvexxy below.
“TX-001HR is the first bio-identical combination hormone therapy of estradiol and progesterone to demonstrate safety and efficacy data in a large, well-controlled, randomized clinical trial. These data support the New Drug Application filed on
The posters and presentations will be made available in the Investors & Media section of the company’s website at www.therapeuticsmd.com.
Details of the presentations for TX-001HR include:
Title: TX-001HR is Associated with a Clinically Meaningful Effect on Vasomotor Symptoms
Session Date/Time:
Title: Effects of TX-001HR on Uterine Bleeding Rates in Menopausal Women with Vasomotor Symptoms
Session Date/Time:
Title: Progesterone Bioavailability for Preventing Endometrial Stimulation with a Continuous-combined regimen of TX-001HR (oral estradiol and micronized progesterone capsules)
Session Date/Time:
Title: 17β-estradiol/progesterone in a Single Oral Softgel Capsule (TX-001HR) Significantly Reduced Moderate-to-Severe Vasomotor Symptoms without Endometrial Hyperplasia
Session Date/Time:
Details of the presentations for Imvexxy (TX-004HR) include:
Title: Symptomatic Vulvar and Vaginal Atrophy (VVA) Relief was Achieved with Negligible to Very Low Systemic Absorption of Estradiol with TX-004HR, a Vaginal, Estradiol, Softgel Capsule: PK Comparison to Systemic and a Vaginal Estradiol
Session Date/Time:
Title: Ultra-low Doses of TX-004HR (Estradiol Vaginal Softgel Capsule) Improve Symptoms of Vulvar and Vaginal Atrophy while Maintaining Serum Levels of Estradiol within the
Session Date/Time:
Title: TX-004HR Provides Robust Improvement of Symptomatic Postmenopausal Vulvar and Vaginal Atrophy (VVA) with Negligible to Very Low Systemic Absorption of Estradiol: Results of Phase 1 and 3 Clinical Trials
Session Date/Time:
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 http://imvexxy.com/pi.pdf for the Full Prescribing Information, including the Boxed Warning.
About TherapeuticsMD, Inc.
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: whether the
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Source:
TherapeuticsMD, Inc.
Investor Contact:
Nichol Ochsner, 561-961-1900
Vice President, Investor Relations
nochsner@TherapeuticsMD.com