TherapeuticsMD Announces Presentations on ANNOVERA™ at the 2019 Annual Meeting of the American Society for Reproductive Medicine
BOCA RATON, Fla.--(BUSINESS WIRE)--Oct 11, 2019--
TherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative women’s healthcare company, today announced the presentation of ANNOVERA™ (segesterone acetate and ethinyl estradiol vaginal system) findings at the annual meeting of the American Society for Reproductive Medicine (ASRM) being held in Philadelphia, PA on October 12-16, 2019.
“We are excited to present data on cycle control, bleeding discontinuations, and endometrial histology safety in women who used ANNOVERA for one year to prevent pregnancy,” said Dr. Brian Bernick, Co-founder and Director of TherapeuticsMD. “Additional findings suggest that the use of ANNOVERA for 13 cycles does not adversely affect a woman’s return to fertility.”
The posters and presentations will be made available on the Investors & Media section of the company’s website at www.therapeuticsmd.com.
October 14, 2019
Bleeding Patterns and Endometrial Safety with a 1-Year, Segesterone Acetate/Ethinyl Estradiol Contraceptive Vaginal System (Program ID: O-24)
October 16, 2019
Return to Fertility After 1-Year Use of a Segesterone Acetate/Ethinyl Estradiol Contraceptive Vaginal System Use (Poster: P‐502)
ANNOVERA IMPORTANT SAFETY INFORMATION
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
See full prescribing information for complete boxed warning.
ANNOVERA is contraindicated and should not be used in women with a high risk of arterial or venous thrombotic diseases; current or history of breast cancer or other estrogen- or progestin-sensitive cancer; liver tumors, acute hepatitis, or severe (decompensated) cirrhosis; undiagnosed abnormal uterine bleeding; hypersensitivity to any of the components of ANNOVERA; and use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.
WARNINGS AND PRECAUTIONS
The most common adverse reactions reported in at least 5% of women who received ANNOVERA were: headache/migraine, nausea/vomiting, vulvovaginal mycotic infection/candidiasis, lower/upper abdominal pain, dysmenorrhea, vaginal discharge, urinary tract infection, breast pain/tenderness/discomfort, bleeding irregularities including metrorrhagia, diarrhea, and genital pruritus.
Drugs or herbal products that induce certain enzymes, including CYP3A4, may decrease the effectiveness of ANNOVERA or increase breakthrough bleeding. Counsel patients to use a back-up or alternative method of contraception when enzyme inducers are used with ANNOVERA.
ANNOVERA is a progestin/estrogen combination hormonal contraceptive indicated for use by females of reproductive potential to prevent pregnancy.
Limitation of Use: ANNOVERA has not been adequately studied in females with a body mass index of >29 kg/m 2.
Please note that this information is not comprehensive.Please click here for the Full Prescribing Information, including BOXED WARNING.
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.
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 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; 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; 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 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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CONTACT: Investor Contact
Vice President Investor Relations
561-961-1900, ext. 2088
KEYWORD: UNITED STATES NORTH AMERICA FLORIDA PENNSYLVANIA
INDUSTRY KEYWORD: HEALTH CONSUMER WOMEN GENERAL HEALTH PHARMACEUTICAL
SOURCE: TherapeuticsMD, Inc.
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PUB: 10/11/2019 07:00 AM/DISC: 10/11/2019 07:01 AM