“It’s important for a woman to have a discussion with her healthcare provider to learn about effective treatment options available to navigate changes and make informed decisions about her sexual and reproductive health,” said Dawn Halkuff, Chief Commercial Officer of TherapeuticsMD. “TherapeuticsMD continues to generate awareness of treatment options available to women through our consumer campaigns ‘Unapologetically ANNOVERA®’ and IMVEXXY®’s ‘Sex Care is Self-Care,’ both designed to empower a woman to self-advocate, start the conversation with her healthcare provider, and ask about ANNOVERA (segesterone acetate and ethinyl estradiol vaginal system) and IMVEXXY (estradiol vaginal inserts).”
TherapeuticsMD celebrated “World Contraception Day” with healthcare professional communication outreach, social posts on the Company’s brand channels, and media stories featuring leading medical experts, about innovative new contraceptive options, such as ANNOVERA. ANNOVERA, which was developed to address the needs of women who desire a long-lasting form of birth control without requiring a procedure for insertion and removal coupled with the patient control and immediate reversibility aspects of short-acting contraceptive products, was highlighted in the October issue of Contemporary OBGYN.
ANNOVERA continues to experience growing demand in orders from wholesalers, retail pharmacies and online distributors as well as the Company’s expansion into secondary channels, such as public health and the military. The Company believes that industry prescription tracking databases do not fully capture the diversity of prescriptions being filled in these multiple channels.
In honor of Menopause Awareness Month, TherapeuticsMD kicked off a video series called “Menopause Below the Belt.” The video series seeks to improve dialogue about menopause and vulvar and vaginal atrophy (VVA) and encourage women to discuss their menopause symptoms with their healthcare providers. TherapeuticsMD also recently sponsored the Oprah Video on the Myths & Facts of Menopause and the supporting article on OprahMag.com.
IMPORTANT RISK INFORMATION FOR ANNOVERA (segesterone acetate and ethinyl estradiol vaginal system)
- Do not use ANNOVERA if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious heart and blood vessel (cardiovascular) side effects from hormonal birth control methods, including death from heart attack, blood clots, or stroke. This risk increases with age and the number of cigarettes you smoke.
- ANNOVERA does not protect against HIV infection (AIDS) and other sexually transmitted infections (STIs)
ANNOVERA can cause serious side effects, including: blood clots; toxic shock syndrome (TSS); liver problems, including liver tumors; high blood pressure; gallbladder problems; changes in the sugar and fat (cholesterol and triglycerides) levels in your blood; headache; irregular or unusual vaginal bleeding and spotting between your menstrual periods; depression; possible cancer in your cervix; swelling of your skin especially around your mouth, eyes, and in your throat (angioedema); dark patches of skin on your forehead, cheeks, upper lip, and chin (chloasma). Call your healthcare provider or get emergency medical care right away if any of these serious side effects occur.
The most common side effects of ANNOVERA include:
ANNOVERA is a ring-shaped vaginal system with hormones used by females to prevent pregnancy.
ANNOVERA has not been adequately studied in females with a body mass index >29 kg/m2.
Please note that this information is not comprehensive. For Full Prescribing Information, including BOXED WARNING, please visit annovera.com/pi.pdf.
IMPORTANT RISK INFORMATION FOR IMVEXXY (estradiol vaginal inserts)
MOST IMPORTANT INFORMATION YOU SHOULD KNOW ABOUT IMVEXXY (an estrogen hormone)
- Using estrogen-alone may increase your chance of getting cancer of the uterus (womb).
- Report any unusual vaginal bleeding right away while you are using IMVEXXY. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause.
- Do not use estrogen-alone or with progestins to prevent heart disease, heart attacks, strokes, or dementia (decline of brain function).
- Using estrogen-alone or with progestin may increase your chances of getting strokes or blood clots.
- Using estrogen-alone or with progestins may increase your chance of getting dementia, based on a study of women 65 years of age or older.
- Using estrogens with progestins may increase your chances of getting heart attacks or breast cancer.
- Talk to your doctor regularly about whether you still need treatment with IMVEXXY.
DO NOT USE IF YOU
- have unusual vaginal bleeding.
- currently have or have had certain cancers.
- currently have or have had blood clots.
- had a stroke or heart attack.
- currently have or have had liver problems.
- have been diagnosed with a bleeding disorder.
- are allergic to IMVEXXY or any of its ingredients.
- think you may be pregnant.
Tell your healthcare provider about all of your medical conditions, including if you:
- have any unusual vaginal bleeding.
- have asthma (wheezing), epilepsy (seizures), diabetes, migraine, endometriosis, lupus, angioedema (swelling of face and tongue), problems with your heart, liver, thyroid, kidneys, or have high calcium levels in your blood.
- are going to have surgery or will be on bed rest. You may need to stop using IMVEXXY.
- are breast feeding.
Tell your healthcare provider about all the medicines you take. IMVEXXY may affect the way other medicines work, and other medicines may affect how IMVEXXY works.
WHEN USING IMVEXXY YOU MAY HAVE
- breast tenderness or pain
- nausea and vomiting
IMVEXXY is a prescription medicine that contains an estrogen hormone in a vaginal insert. It is used after menopause to treat moderate to severe painful intercourse, a symptom of changes in and around your vagina, due to menopause.
Please note that this information is not comprehensive. For Full Prescribing Information, including BOXED WARNING, please visit imvexxy.com/pi.pdf.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch, or call 1-800-FDA-1088. You may also report side effects to TherapeuticsMD at 1-888-228-0150.
About TherapeuticsMD, Inc.
TherapeuticsMD, Inc. is an innovative, leading 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.
Forward-Looking Statements for 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: the effects of the COVID-19 pandemic; the company’s ability to maintain or increase sales of its products; the company’s ability to develop and commercialize IMVEXXY®, ANNOVERA®, and BIJUVA® and obtain additional financing necessary therefor; whether the company will be able to comply with the covenants and conditions under its term loan facility; the potential of adverse side effects or other safety risks that could adversely affect the commercialization of the company’s current or future approved products or preclude the approval of the company’s future drug candidates; whether the FDA will approve the efficacy supplement for the lower dose of BIJUVA; the company’s ability to protect its intellectual property, including with respect to the Paragraph IV notice letters the company received regarding IMVEXXY and BIJUVA; the length, cost and uncertain results of future clinical trials; the company’s reliance on third parties to conduct its manufacturing, research and development and clinical trials; the ability of the company’s licensees to commercialize and distribute the company’s products; the ability of the company’s marketing contractors to market ANNOVERA; 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: https://ir.therapeuticsmd.com/press-releases.