BOCA RATON, Fla.--(BUSINESS WIRE)--TherapeuticsMD, Inc. (NASDAQ:TXMD), an innovative women’s healthcare company, announced the launch of Just Say Vagina to encourage women to speak clearly and directly about their reproductive health. Comedian Whitney Cummings will discuss her journey from serial apologizer to an unapologetic role model who no longer uses euphemisms or apologizes in the way she speaks about birth control.
“I used to apologize a lot. But now I’m encouraging all women to channel their inner superpower and ditch the V word,” explained Whitney Cummings. “I’ve learned that when you use euphemisms, it makes it harder to say what you mean and to ask for what you need. It’s not cha cha. It’s not hoo hah. Just say it. Vagina.”
Whitney Cummings has used hormonal birth control for nearly two decades and recently decided it was time for a switch. She spoke to her doctor and they decided that ANNOVERA® (segesterone acetate and ethinyl estradiol vaginal system) was the right choice for her. ANNOVERA is the first annual, comfortable, and procedure-free birth control. It's a soft and squishy ring that a woman inserts into her vagina. When squeezed, the ring is about the same size as a tampon. ANNOVERA is inserted for 21 days and then removed for seven days each cycle, for one year (13 cycles).
“I always ask my patients ‘how’s your vagina?’” explained Mary Jane Minkin, MD, Yale University School of Medicine. “I want my patients to feel comfortable speaking directly to me about their needs. Once we are all comfortable, I can better support my patient’s wellness and I can help her determine what will work best for her in a more productive and clear way.”
There are consequences when a woman is not comfortable being direct about her contraceptive preferences. In the United States, the unintended pregnancy rate is 45 percent and 41 percent of unintended pregnancies are due to inconsistent use of contraceptives.1,2,3 In addition, women are dissatisfied when it comes to birth control, with 47 percent of female birth control users discontinuing use of a contraceptive method due to a variety of factors, such as side effects, effectiveness, sexual pleasure, partner preference, and cost.4
In addition, an online analysis of more than 724 million social conversations confirmed that women unnecessarily apologize more than men when it comes to reproductive health. In fact, women apologize 30 times more than men when discussing birth control.
"It’s time for open, honest, and unapologetic conversations about birth control. We are proud to partner with Whitney Cummings to usher in the next generation of empowered women," said Dawn Halkuff, Chief Commercial Officer of TherapeuticsMD. "It is important for women to be educated about their bodies and the contraceptive options available to them. We hope that Whitney inspires other women to be more comfortable and candid when discussing their reproductive health needs."
You can learn more at www.JustSayVagina.com, where you will find a doctor discussion guide.
About ANNOVERA
ANNOVERA is the first and only FDA-approved long-lasting, reversible contraceptive for women of reproductive age that is patient-controlled and procedure-free. ANNOVERA was developed by the global non-profit research organization, Population Council and has been licensed to TherapeuticsMD for the U.S. market.
IMPORTANT RISK INFORMATION
- Do not use ANNOVERA (segesterone acetate and ethinyl estradiol vaginal system) 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).
DO NOT USE ANNOVERA IF YOU
- have or have had a blood clot in your arms, legs, lungs, or eyes.
- have had a stroke.
- have reduced blood flow to your brain (cerebrovascular disease).
- have reduced blood flow or blockage in 1 or more of the arteries that supply blood to your heart (coronary artery disease).
- have had a heart attack.
- have heart rhythm or heart valve problems that increase your risk of having blood clots, such as an infection of the inner lining of the heart and heart valves or a type of irregular heartbeat called atrial fibrillation.
- have a problem with your blood that makes it clot more than normal.
- have high blood pressure that is not controlled with medicine or have high blood pressure with blood vessel damage.
- have diabetes and are over 35 years old; have diabetes with high blood pressure or problems with your kidneys, blood vessels, eyes, or nerves; or have had diabetes for longer than 20 years.
- have headaches with changes in vision, numbness or weakness, have migraine headaches with aura, or are over age 35 years old and have any type of migraine headaches.
- have liver disease or liver tumors.
- have or have had breast cancer or any cancer that is sensitive to the female hormones estrogen or progesterone.
- have unexplained vaginal bleeding.
- are allergic to segesterone acetate, ethinyl estradiol, or any of the ingredients in ANNOVERA.
- take any Hepatitis C drug combination medicine containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.
WARNINGS
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:
- headache, including migraine
- nausea/vomiting
- vaginal yeast infection (candidiasis)
- lower/upper abdomen pain
- painful periods
- vaginal discharge
- urinary tract infection
- breast pain/tenderness
- irregular vaginal bleeding
- diarrhea
- genital itching
USE
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.
The risk information provided here is not complete. To learn more, review the ANNOVERA Patient Information and talk with your healthcare provider or pharmacist. The FDA-approved product labeling, including Patient Information, can be found at annovera.com/pi.pdf.
You may report side effects to the FDA at www.fda.gov/medwatch or by calling 1-800-FDA-1088.
You may also report side effects to TherapeuticsMD at 1-888-228-0150.
About TherapeuticsMD
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.
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: 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; whether the company will be able to successfully divest its vitaCare business and the proceeds that may be generated by such divestiture; 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: www.therapeuticsmd.com/pressreleases.aspx.
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1 Guttmacher Institute. Contraceptive Use in the United States. Available at: https://www.guttmacher.org/fact-sheet/contraceptive-use-united-states
2 Bearak J, et al. Global, regional, and subregional trends in unintended pregnancy and its outcomes from 1990 to 2014: estimates from a Bayesian hierarchical model. Lancet Global Health. April 2018;6(4): e380-e9.
3 Finer LB, et al. Declines in Unintended Pregnancy in the United States, 2008–2011. New England Journal of Medicine. March 2016;374(9 9):843-52).
4 Data on file. Survey Report: Birth Control ATU. Ipsos Healthcare Team; May 12th, 2020.
