Largest online practice for women’s health now offers the first FDA-approved long-lasting birth control method that does not require a medical procedure
BOCA RATON, Fla. & SAN FRANCISCO--(BUSINESS WIRE)--Jul. 15, 2020-- TherapeuticsMD, an innovative women’s healthcare company, and Nurx, the largest online practice for women’s health, today announced an arrangement to expand access to ANNOVERA® (segesterone acetate and ethinyl estradiol vaginal system), a first of its kind annual birth control ring. ANNOVERA is the first FDA-approved long-lasting birth control method that does not require a medical procedure. At a time when women are facing significant barriers to reproductive healthcare, this arrangement will greatly expand access to this highly effective and innovative form of contraception to Nurx’s 300,000 patients across the country.
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Nurx has seen a 50 percent increase in birth control requests since early March, a trend that has continued as one in three women are reporting significant difficulties accessing contraception and reproductive healthcare due to the COVID-19 pandemic.1 Nurx has also seen an increase in patients requesting longer-term forms of contraception that can be administered at home, making ANNOVERA a viable option for patients who are interested in a long-lasting, self-managed, and effective form of birth control.
“We are excited to expand access to ANNOVERA via the Nurx virtual clinic, which provides a convenient option for women to consult with a doctor about reproductive treatment options as well as the ability to receive their contraception with the convenience of home delivery,” said TherapeuticsMD Chief Commercial Officer Dawn Halkuff.
ANNOVERA is a flexible, silicone ring that is inserted into the vagina and releases a steady dose of progestin and estrogen to suppress ovulation and prevent pregnancy. ANNOVERA is self-inserted and left in place for 21 continuous days and then removed for 7 days, a process that is repeated for each cycle. ANNOVERA should be washed and dried before insertion and after removal and can be stored in its plastic case during the 7 days removal. ANNOVERA is effective for 13 cycles. Please see Important Safety Information, including Boxed Warning, for ANNOVERA below.
“COVID-19 is magnifying existing barriers to women’s healthcare while simultaneously introducing new roadblocks,” said Nurx VP of Marketing Katelyn Watson. “As part of our commitment to empower our patients and their reproductive health decisions, we’re excited to partner with TherapeuticsMD and expand access to a novel, convenient, and effective form of contraception.”
Nurx offers over 100 types of birth control, including the pill, patch, ring, and shot, and accepts health insurance. Patients who are interested in obtaining a birth control prescription through Nurx are asked to complete a dynamic health survey through the Nurx app. They are then matched with a Nurx medical provider who consults with the patient. If the Nurx provider approves their request, their birth control prescription will arrive in discreet packaging. After their initial consultation, Nurx patients also have unlimited access to their provider for one year, allowing them to ask as many birth control questions as they'd like.
Nurx is available to nearly 90 percent of the U.S. population. The full list of states where Nurx is available includes Alabama, California, Colorado, District of Columbia, Florida, Georgia, Illinois, Indiana, Iowa, Kentucky, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New York, North Carolina, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, and Wisconsin.
Nurx patients can learn more about Annovera at https://www.nurx.com/annovera.
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.
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.
Please note that this information is not comprehensive. For Full Prescribing Information, including BOXED WARNING, please visit annovera.com/pi.pdf.
Nurx is a health tech company providing convenient, affordable, and personalized care for sensitive health needs. By reimagining the healthcare experience, Nurx offers patients transparent pricing and judgement-free care whenever and wherever works best for them. We believe everyone should have the freedom to live well and be in charge of their healthcare decisions, regardless of their circumstances. From diagnosis to delivery, we make every part of getting healthy and staying healthy, better.
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 Company’s ability to protect the intellectual property related to its products; 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®, BIJUVA® 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 facility, including the conditions to draw an additional tranche thereunder and whether the lender will make such tranche available; 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.
1 Early Impacts of the COVID-19 Pandemic: Findings from the 2020 Guttmacher Survey of Reproductive Health Experiences
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