TherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative women’s healthcare company, today announced Phase 3 menstrual bleeding profile data for ANNOVERA (segesterone acetate and ethinyl estradiol vaginal system) was presented at the 2021 American College of Obstetricians and Gynecologists (ACOG) Annual Clinical and Scientific Meeting conducted virtually from April 30 to May 2, 2021.
“Menstrual bleeding patterns for women may change with contraceptive use, and predictable bleeding (cycle control) is a key factor that impacts women’s selection, adherence and continuation of combined hormonal contraception. In clinical studies, ANNOVERA showed predictable scheduled bleeding for most women. An unpredictable bleeding profile is very important because it is a common reason that women tend to switch among different contraceptives,” said David F. Archer, MD at Eastern Virginia Medical School.
Results were pooled from two identically designed, open-label Phase 3 trials of ANNOVERA. Bleeding data were available from 2,070 women a total of 453,622 patient-days evaluated for bleeding. Based on ANNOVERA use for up to 13 cycles, a daily average of 94.8% to 97.6% of women reported no unscheduled bleeding in each cycle. The daily percentage of women presenting unscheduled bleeding (≤1.4%) or spotting (≤3.6%) was consistently low throughout the 13 cycles of ANNOVERA use. The median number of unscheduled bleeding/spotting days remained stable across the 13 cycles of ANNOVERA use. Less than 2% of women discontinued ANNOVERA due to bleeding-related adverse events.
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.
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
- vaginal yeast infection (candidiasis)
- lower/upper abdomen pain
- painful periods
- vaginal discharge
- urinary tract infection
- breast pain/tenderness
- irregular vaginal bleeding
- genital itching
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.
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
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 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.
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