September is Menopause Awareness month, and TherapeuticsMD aims to de-stigmatize and provide education every woman should know about menopause
In the next ten years, there will be more than 1.2 billion women worldwide in menopausei
More than 80% of women experience some symptoms around menopausei
This September, TherapeuticsMD, Inc., an innovative women’s healthcare company (NASDAQ: TXMD), is recognizing Menopause Awareness Month, as it aims to empower the 64 million women in the U.S. currently in menopauseii. To celebrate this month and all menopausal women, TherapeuticsMD encourages people to Take Pause and learn about menopause.
Many people are aware of common menopause symptoms like hot flashes, which impact 85% of menopausal womeniii, but vulvar and vaginal atrophy (“VVA”), a condition experienced by more than half of menopausal women, is rarely discussed. While VVA causes symptoms like vaginal dryness, burning, itching, recurrent urinary tract infections (“UTIs”) and painful sex, 81% of these women are unaware that VVA is a medical conditioniv.
“While women today are prioritizing their health more than ever before, menopause continues to be misunderstood and is rarely discussed,” said Kristen Landon, Senior Vice President, Marketing, TherapeuticsMD. “At TherapeuticsMD, we want to change how menopause is portrayed in society and to help educate people about these naturally occurring changes to a woman’s body during this life stage. The only way to do that is to help normalize menopause, ensure that women know they are not alone, and inspire them to feel comfortable to speak up and take action. This Menopause Awareness Month, we want to encourage women to Take Pause and give their bodies, including their vaginas, the care and love they deserve.”
As part of the Take Pause initiative, TherapeuticsMD is distributing a series of educational videos and “pausable” social posts on the IMVEXXY® (estradiol vaginal inserts) Facebook page. This important information aims to reduce the stigma associated with menopause symptoms like painful sex, and to educate women on available treatment options, including IMVEXXY.
- The educational video series will feature Dr. Rebecca Brightman, Board-Certified OBGYN and Menopause Specialist, discussing vulvar and vaginal atrophy, which causes painful sex.
- The pausable and shareable social ads encourage people to learn more about menopause and some of its bothersome symptoms like painful sex. The messaging brings awareness to a stage of a woman’s life that continues to be ignored by society.
Through the Take Pause initiative and our recent Long May She REIGN Campaign, TherapeuticsMD is committed to raising awareness of the impact of menopause and educating women about available treatment options. Women can learn more about moderate to severe painful sex due to menopause at IMVEXXY.com and moderate to severe hot flashes at BIJUVA.com.
IMVEXXY (estradiol vaginal inserts) Important Risk Information
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.
IMPORTANT RISK INFORMATION
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
The risk information provided here is not complete. To learn more, talk about IMVEXXY with your healthcare provider or pharmacist. The FDA-approved product labeling can be found at IMVEXXY.com/pi.pdf.
BIJUVA® (estradiol and progesterone) Important Risk Information
IMPORTANT RISK INFORMATION
Most important information you should know about BIJUVA (a combination of estrogen and progestogen):
- Do not use estrogens with or without progestogens to prevent heart disease, heart attacks, strokes, or dementia (decline of brain function).
- Using estrogens with progestogens may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots.
- Using estrogens with progestogens may increase your chance of getting dementia, based on a study of women 65 years of age and older.
- Using estrogen-alone may increase your chance of getting cancer of the uterus.
- Do not use estrogen-alone to prevent heart disease, heart attacks, strokes, or dementia (decline of brain function).
- Using estrogen-alone may increase your chances of getting strokes or blood clots.
- Using estrogen-alone may increase your chance of getting dementia, based on a study of women 65 years of age and older.
- You and your healthcare provider should talk regularly about whether you still need treatment with BIJUVA.
DO NOT USE BIJUVA IF YOU
- Have had your uterus (womb) removed (hysterectomy). BIJUVA contains a progestogen to decrease the chance of getting cancer of the uterus. If you do not have a uterus, you do not need a progestogen and you should not use BIJUVA.
- Have any unusual vaginal bleeding. 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.
- Have been diagnosed with a bleeding disorder.
- Have or have had certain cancers. Estrogens may increase the chances of getting certain types of cancers, including cancer of the breast or uterus. If you have or have had cancer, talk with your healthcare provider about whether you should use BIJUVA.
- Have or have had blood clots.
- Had a stroke or heart attack.
- Have or have had liver problems.
- Are allergic to BIJUVA or any of its ingredients.
Ask a doctor before use if you:
- Have high levels of fat in your blood (triglycerides).
- Have any unusual vaginal bleeding.
- Have any other medical conditions that may become worse while you are using BIJUVA, such as: asthma (wheezing); diabetes; a genetic problem called porphyria; lupus; hypertension (high blood pressure); have high calcium in your blood; epilepsy (seizures); migraine; endometriosis; angioedema (swelling of face or tongue); problems with your heart, liver, thyroid or kidneys.
- Are going to have surgery or will be on bed rest.
- Are pregnant or think you may be pregnant. BIJUVA is not for pregnant women.
- Are breastfeeding.
Tell your doctor or pharmacist about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
WHEN USING BIJUVA, YOU MAY HAVE
● Breast tenderness ● Headache ● Vaginal bleeding ● Vaginal discharge ● Pelvic pain
Call your doctor right away if you get any of the following warning signs:
- New breast lumps
- Unusual vaginal bleeding
- Changes in vision or speech
- Sudden new severe headaches
- Severe pains in your chest or legs with or without shortness of breath, weakness and fatigue
BIJUVA is a prescription medicine that contains two hormones, an estrogen and a progestogen. BIJUVA is used after menopause to reduce moderate to severe hot flashes in women with a uterus.
The risk information provided here is not complete. To learn more, review the BIJUVA Patient Information and talk about BIJUVA with your healthcare provider or pharmacist. The FDA-approved product labeling, including Patient Information, can be found at BIJUVA.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.
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.
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, or obtain an investment in, its vitaCare business and how the proceeds that may be generated by any such divestiture or investment will be utilized; 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 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.
i Sussman et al. Prevalence of menopausal symptoms among mid-life women: findings from medical records. BMC Women’s Health. 2015 15:58. doi: 10.1186/s12905-015-0217-y.
ii Wysocki S, Kingsberg S, Krychman M. Management of vaginal atrophy: implications from the REVIVE survey. Clin Med Insights Reprod Health. 2014;8:23-30
iii Goodman NF, Cobin RH, Ginzburg SB, Katz IA, Woode DE; American Association of Clinical Endocrinologists. American Association of Clinical Endocrinologists Medical Guidelines for Clinical Practice for the diagnosis and treatment of menopause. Endocr Pract. 2011 Nov-Dec;17 Suppl 6:1-25. doi: 10.4158/ep.17.s6.1. PMID: 22193047.
iv Kingsberg SA et al. The Women’s EMPOWER Survey: Identifying Women’s Perceptions on Vulvar and Vaginal Atrophy and Its Treatment J Sex Med. 2017;14:413-424.
Lisa M. Wilson
In-Site Communications, Inc.