-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
Title: Effects of TX-001HR on Uterine Bleeding Rates in
Menopausal Women with Vasomotor Symptoms
Title: Progesterone Bioavailability for Preventing Endometrial
Stimulation with a Continuous-combined regimen of TX-001HR (oral
estradiol and micronized progesterone capsules)
Title: 17β-estradiol/progesterone in a Single Oral Softgel
Capsule (TX-001HR) Significantly Reduced Moderate-to-Severe Vasomotor
Symptoms without Endometrial Hyperplasia
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
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
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
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.
About TherapeuticsMD, Inc.
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
Nichol Ochsner, 561-961-1900
Vice President, Investor Relations