TherapeuticsMD Announces Commercial Availability of Imvexxy™ 4 mcg
Published: Sep 13, 2018
“We are incredibly excited to launch the 4 mcg dose of Imvexxy, which is the lowest dose vaginal estradiol product approved by the FDA, and which follows the 10 mcg dose that became commercially available early in August,” said Robert Finizio, Chief Executive Officer of TherapeuticsMD. “These two distinct doses meet the different needs of women and their healthcare providers. Imvexxy was designed with clinical and physical attributes to help provide a positive user experience. Imvexxy is administered as a softgel vaginal insert that dissolves completely within hours, so patients can use it any time of day.”
For postmenopausal women with VVA, Imvexxy provides improvement in moderate-to-severe dyspareunia within 12 weeks, and beginning as early as two weeks for some women, which was a secondary endpoint in the pivotal Phase 3 clinical trial of Imvexxy. In general, women should begin treatment at the 4 mcg dose, and may consider the 10 mcg dose depending on their clinical response. Imvexxy is inserted about two inches into the vagina to re-estrogenize the tissue in and around the vagina. Imvexxy is administered daily for two weeks followed by only twice a week dosing to maintain treatment.
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.3
VVA affects an estimated 32 million postmenopausal women in the US.4 Only about seven percent (2.3 million) of these women receive prescription treatment. Nearly one out of two women will experience pain during intercourse due to VVA at some point during their postmenopausal years.5
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 IMVEXXY™, ANNOVERA 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.
1 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.
2 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.
3 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.
4 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, Krychman M, Graham S, Bernick B, Mirkin S. The Women’s EMPOWER Survey: Identifying women’s perceptions on vulvar and vaginal atrophy and its treatment. J Sex Med. 2017;14:413‐424.
5 Kingsberg SA, Krychman M, Graham S, Bernick B, Mirkin S. The Women’s EMPOWER Survey: Identifying women’s perceptions on vulvar and vaginal atrophy and its treatment. J Sex Med. 2017;14:413‐424.
Nichol Ochsner, 561-961-1900, ext. 2088
Vice President Investor Relations
Source: TherapeuticsMD, Inc.