TherapeuticsMD Announces Presentations on ANNOVERA™ at the 2019 Annual Meeting of the American Society for Reproductive Med...
October 11 2019 - 07:00AM
Business Wire
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.
Oral
Presentation
Date:
October 14, 2019
Time:
12:00-12:15 PM
Title:
Bleeding Patterns and Endometrial Safety
with a 1-Year, Segesterone Acetate/Ethinyl Estradiol Contraceptive
Vaginal System (Program ID: O-24)
Poster
Date:
October 16, 2019
Time:
6:30-7:45 AM
Title:
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.
- Females over 35 years old who smoke should not use
ANNOVERA.
- Cigarette smoking increases the risk of serious
cardiovascular events from combination hormonal contraceptive
use.
CONTRAINDICATIONS
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
- Stop ANNOVERA if a thrombotic or thromboembolic event occurs,
and at least 4 weeks before and through 2 weeks after major
surgery. Start ANNOVERA no earlier than 4 weeks after delivery, in
females who are not breastfeeding. Consider cardiovascular risk
factors before initiating in all females, particularly those over
35 years.
- Discontinue if jaundice occurs.
- Stop ANNOVERA prior to starting therapy with the combination
drug regimen ombitasvir/paritaprevir/ritonavir. ANNOVERA can be
restarted 2 weeks following completion of this regimen.
- Do not prescribe ANNOVERA for females with uncontrolled
hypertension or hypertension with vascular disease. Monitor blood
pressure and stop use if blood pressure rises significantly in
females with well-controlled hypertension.
- Monitor glucose in pre-diabetic or diabetic females taking
ANNOVERA. Consider an alternate contraceptive method for females
with uncontrolled dyslipidemias.
- Patients using ANNOVERA who have a significant change in
headaches or irregular bleeding or amenorrhea should be evaluated.
ANNOVERA should be discontinued if indicated.
- Other warnings include: gallbladder disease; depression;
cervical cancer; increased serum concentrations of binding
globulins; hereditary angioedema; chloasma (females who tend to
develop chloasma should avoid exposure to the sun or UV radiation
while using ANNOVERA); toxic shock syndrome (TSS) (if a patient
exhibits symptoms of TSS, remove ANNOVERA, and initiate appropriate
medical treatment); vaginal use (ANNOVERA may not be suitable
for females with conditions that make the vagina more susceptible
to vaginal irritation or ulceration).
ADVERSE REACTIONS
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.
DRUG INTERACTIONS
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.
INDICATION
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/m2.
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.
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 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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version on businesswire.com: https://www.businesswire.com/news/home/20191011005086/en/
Investor Contact Nichol Ochsner Vice President Investor
Relations 561-961-1900, ext. 2088 Nochsner@TherapeuticsMD.com
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