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"IMVEXXY is a bio-identical vaginal estrogen product that offers a fraction of the estrogen contained in the average doses of many existing products currently on the market," said Brian Bernick, MD, Chief Clinical Officer of
"We are excited to bring IMVEXXY to market as
About Dyspareunia and Vulvar and Vaginal Atrophy (VVA)
VVA is a component of genitourinary syndrome of menopause (GSM), which may include, but is not limited to, genital symptoms of dryness, burning and irritation, sexual symptoms such as decreased lubrication, discomfort, and pain, and urinary symptoms such as urgency, dysuria, and recurrent urinary tract infections.1 VVA is a chronic, progressive condition that leads to distressing symptoms and can progressively worsen if not treated.2
VVA is a condition that develops when the body makes less estrogen due to menopause. Without sufficient estrogen, the vaginal tissue becomes thin, dry, and less elastic. The vaginal canal can also narrow and shorten. Insufficient estrogen can also decrease vaginal fluids, change the acid balance of the vagina, and weaken pelvic floor muscles. All these factors can lead to dyspareunia.2
VVA affects an estimated 32 million postmenopausal women in the US. Only about seven percent (2.3 million) of these women receive prescription treatment.3 Nearly 1 out of 2 women will experience pain during intercourse due to VVA at some point during their lives.3
"Studies have shown that many women are not seeking treatment for VVA and 81% are unaware that VVA is a treatable medical condition and part of a constellation of symptoms associated with loss of estrogens," said Dr.
IMVEXXY For the Treatment of Moderate to Severe Dyspareunia Due to Menopause
Imvexxy's mechanism of action is the re-estrogenization of the tissue in and around the vagina. IMVEXXY's distinctive formulation ensures that it dissolves completely without mess, so patients can use it any time of day by placing the softgel capsule in the lower part of the vagina to treat the vulva and vagina. IMVEXXY is administered daily for two weeks followed by only twice a week dosing. Nine out of 10 patients who participated in a clinical trial reported that IMVEXXY was "easy to use."4
The most common adverse reaction with IMVEXXY (incidence ≥3 percent) and greater than placebo was headache. There were no clinically significant differences in AEs observed between treatment and placebo groups.5 Important safety information for IMVEXXY, including the boxed warning for endometrial cancer, cardiovascular disorders, breast cancer, and probable dementia, is provided below. The full prescribing information may be viewed by visiting www.imvexxy.com.
As part of the
Conference Call Information
Wednesday, May 30, 2018
8:00 AM EDT
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Additionally, a live webcast can be accessed on the company's website, www.therapeuticsmd.com, on the Home Page or under the "Investors & Media" section. A digital recording of the conference call will be available for replay beginning two hours after the call's completion and for at least 30 days with the dial-in (855) 859-2056 or international (404) 537-3406 and Conference ID: 4757309.
IMPORTANT SAFETY INFORMATION
WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER and PROBABLE DEMENTIA
See full prescribing information for complete boxed warning.
Estrogen Plus Progestin Therapy
- 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 imvexxy.com/pi.pdf for the Full Prescribing Information, including the Boxed Warning.
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
Vice President Investor Relations
561-961-1900, ext. 2088
Senior Vice President, Health
- Portman DJ, Gass ML;
Vulvovaginal Atrophy Terminology Consensus Conference Panel. Genitourinary syndrome of menopause: new terminology for vulvovaginal atrophy from the International Society for the Study of Women's Sexual Health and the North American Menopause Society. Menopause. 2014;21(10):1063-1068. The North American Menopause Society. Management of symptomatic vulvovaginal atrophy: 2013 position statement of The North American Menopause Society. Menopause. 2013;20(9):888–902.
- Wysocki S, Kingsberg S, Krychman M. Management of vaginal atrophy: implications from the REVIVE survey.
Clin Med Insights Reprod Health. 2014;8:23-30. Kingsberg SA, Kroll R, Goldstein I, et al. Patient acceptability and satisfaction with a low-dose solubilized vaginal estradiol softgel capsule, TX-004HR. Menopause. 2017;24:894-899.
- Constantine GD, Simon JA, Pickar JH, et al. The REJOICE trial: a phase 3 randomized, controlled trial evaluating the safety and efficacy of a novel vaginal estradiol soft-gel capsule for symptomatic vulvar and vaginal atrophy. Menopause. 2017;24:409-416.
- Archer DF, Constantine GD, Simon J, et al.TX-004HR Vaginal Estradiol Has Negligible to Very Low Systemic Absorption of Estradiol. Menopause 2017;24:510-516.
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