TherapeuticsMD Announces Oral and Poster Presentations on BIJUVA™ and ANNOVERA™ at the Endocrine Society 2019 Annual Meet...

Date : 03/25/2019 @ 11:00AM
Source : Business Wire
Stock : Therapeuticsmd, Inc. (MM) (TXMD)
Quote : 2.25  -0.02 (-0.88%) @ 4:59AM

TherapeuticsMD Announces Oral and Poster Presentations on BIJUVA™ and ANNOVERA™ at the Endocrine Society 2019 Annual Meet...

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Four Posters Will Present BIJUVA Phase 3 REPLENISH Data About Improvements in Hot Flushes, Night Sweats, Sweating, Quality of Sleep, and Incidence of Vaginal Bleeding in Postmenopausal Women

One Oral Presentation and One Poster Will Present ANNOVERA Phase 3 Data About Antiovulatory Effects and Impact on Lipids and Hepatic Proteins

TherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative, leading women’s healthcare company, today announced the schedule of presentations on BIJUVA™ (estradiol and progesterone capsules, 1 mg/100 mg) and ANNOVERA™ (segesterone acetate/ethinyl estradiol vaginal system) at the Endocrine Society 2019 Annual Meeting in New Orleans, on March 23-26, 2019.

“Data from the REPLENISH Phase 3 trial for BIJUVA showed improvements in hot flushes, night sweats, sweating, and quality of sleep. We are pleased to continue to present positive clinical data on BIJUVA in menopause quality of life (MENQOL) assessments, including difficulty in sleeping, which is a common complaint in postmenopausal women with vasomotor symptoms,” said TherapeuticsMD Chief Medical Officer Sebastian Mirkin, M.D. “The REPLENISH data also showed a low incidence of vaginal bleeding. Vaginal bleeding associated with hormone therapy is the most common reason for discontinuation of treatment.”

BIJUVA is the first and only FDA-approved, bio-identical hormone therapy combination of estradiol and progesterone in a single, oral capsule for the treatment of moderate-to-severe vasomotor symptoms (commonly known as hot flashes or flushes) due to menopause in women with a uterus. Please see the Important Safety Information, including Boxed Warning, for BIJUVA below.

Data on ANNOVERA, a contraceptive vaginal system that contains a novel progestin, segesterone acetate, demonstrated potent antiovulatory effects in preventing pregnancy without the androgenic, estrogenic or glucocorticoid side effects that are often associated with other contraceptive hormone products.

“We are enthusiastic about the ANNOVERA data that confirms this new progestin is highly effective and comparable to the most effective birth control methods already on the market today, while avoiding daily fluctuations in hormone levels given its controlled release, helping to provide excellent cycle control,” said Dr. Brian Bernick, Co-founder and Director of TherapeuticsMD.

ANNOVERA is the first long-acting prescription birth control that is patient-controlled, procedure-free and reversible. This small, soft, flexible ring prevents ovulation for an entire year (13 cycles) and can be inserted and removed by a woman at her discretion in repeated four-week cycles (remaining in place continuously for three weeks followed by removal for one week). Please see the Important Safety Information, including Boxed Warning, for ANNOVERA below.

The posters and presentations will be made available on the Investors & Media section of the company’s website at www.therapeuticsmd.com.

Poster Presentations

Date: Saturday, March 23Time and Location: 1:00-3:00 PM, Ernest N. Morial Convention Center, Expo HallTitle: Combined Bioidentical Estradiol and Progesterone Capsules Improved Quality of Sleep in Postmenopausal Women with Vasomotor SymptomsAuthors: N Santoro, G Constantine, R Kagan, S Graham, B Bernick, S Mirkin

Date: Saturday, March 23Time and Location: 1:00-3:00 PM Ernest N. Morial Convention Center, Expo HallTitle: Bioidentical Estradiol and Progesterone Improved Hot Flushes, Night Sweats and SweatingAuthors: J Liu, AM Kaunitz, JA Simon, B Bernick, S Mirkin

Date: Saturday, March 23Time and Location: 1:00-3:00 PM, Ernest N. Morial Convention Center, Expo HallTitle: Predictors of Vaginal/Uterine Bleeding with Oral TX-001HR (Estrogen andProgesterone) Capsules Taken for Menopausal Vasomotor SymptomsAuthors: G Constantine, SR Goldstein, JH Pickar, S Graham, B Bernick, S Mirkin

Date: Saturday, March 23Time and Location: 1:00-3:00 PM, Ernest N. Morial Convention Center, Expo HallTitle: A Novel 1-Year Contraceptive Vaginal System Delivering Segesterone Acetate and Ethinyl Estradiol: Effects on Lipids and other Hepatic ProteinsAuthors: DF Archer, MA Thomas, R Sitruk-Ware, J Liu, B Bernick, S Mirkin, R Merkatz, N Kumar, DL Blithe

Date: Saturday, March 23Time and Location: 1:00-3:00 PM, Ernest N. Morial Convention Center, Expo HallTitle: Nonsmokers Benefit from Lower Doses of an Estradiol/Progesterone Combination: Results of the REPLENISH TrialAuthors: G Constantine, S Graham, B Bernick, S Mirkin

Oral Presentation

Date: Tuesday, March 26Time and Location: 9:45-11:30 AM, OR33-Modulation of HGP Axis in the FemaleTitle: Low Systemic Levels of Segesterone Acetate are Required to Inhibit Ovulation in WomenAuthors: DF Archer, R Sitruk-Ware, S Mirkin, V Brache, RB Merkatz, N Kumar

BIJUVA IMPORTANT SAFETY INFORMATION

BIJUVA is a combination of an estrogen and progesterone indicated in a woman with a uterus for the treatment of moderate-to-severe vasomotor symptoms due to menopause.

 

WARNING: CARDIOVASCULAR DISORDERS, BREAST CANCER, ENDOMETRIAL CANCER, AND PROBABLE DEMENTIA

See full prescribing information for complete boxed warning.

Estrogen Plus Progestin Therapy

  • Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia
  • The Women’s Health Initiative (WHI) estrogen plus progestin substudy reported increased risks of stroke, deep vein thrombosis (DVT), pulmonary embolism (PE), and myocardial infarction (MI)
  • The WHI estrogen plus progestin substudy reported increased risks of invasive breast cancer
  • The WHI Memory Study (WHIMS) estrogen plus progestin ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age of older

Estrogen-Alone Therapy

  • There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens
  • Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia
  • The WHI estrogen-alone substudy reported increased risks of stroke and DVT
  • The WHIMS estrogen-alone ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age or older`

Contraindications

  • BIJUVA is contraindicated in women with any of the following conditions: Undiagnosed abnormal genital bleeding; Known, suspected, or history of cancer of the breast; Known or suspected estrogen-dependent neoplasia; Active DVT, PE, or history of these conditions; Active arterial thromboembolic disease (for example, stroke, MI), or a history of these conditions; Known anaphylactic reaction, angioedema, or hypersensitivity to BIJUVA or any of its ingredients; Known liver impairment or disease; Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders.

Warnings & Precautions

  • An increased risk of PE, DVT, stroke, and MI has been reported with estrogen plus progestin therapy. Should these occur or be suspected, therapy should be discontinued immediately. Risk factors for arterial vascular disease and/or venous thromboembolism (VTE) should be managed appropriately.
  • The WHI substudy of daily estrogen plus progestin after a mean follow-up of 5.6 years reported an increased risk of invasive breast cancer. Observational studies have also reported an increased risk of breast cancer for estrogen plus progestin therapy after several years of use. The risk increased with duration of use an appeared to return to baseline over about 5 years after stopping treatment (only the observational studies have substantial data on risk after stopping). The use of estrogen plus progestin therapy has been reported to result in an increase in abnormal mammograms requiring further evaluation.
  • Endometrial hyperplasia (a possible precursor to endometrial cancer) has been reported to occur at a rate of approximately less than one percent with BIJUVA. Clinical surveillance of all women using estrogen plus progestin therapy is important. Adequate diagnostic measures should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding.
  • The WHI estrogen plus progestin substudy reported a statistically non-significant increased risk of ovarian cancer. A meta-analysis of 17 prospective and 35 retrospective epidemiology studies found that women who used hormonal therapy for menopausal symptoms had an increased risk for ovarian cancer. The exact duration of hormone therapy use associated with an increased risk of ovarian cancer, however, is unknown.
  • In the WHIMS ancillary studies of postmenopausal women 65 to 79 years of age, there was an increased risk of developing probable dementia in women receiving estrogen plus progestin when compared to placebo. It is unknown whether these findings apply to younger postmenopausal women.
  • Estrogens increase the risk of gallbladder disease.
  • Discontinue estrogen if severe hypercalcemia, loss of vision, severe hypertriglyceridemia, or cholestatic jaundice occurs.
  • Monitor thyroid function in women on thyroid replacement hormone therapy.

Adverse Reactions

The most common adverse reactions (≥3%) for BIJUVA are breast tenderness (10.4%), headache (3.4%), vaginal bleeding (3.4%), vaginal discharge (3.4%), and pelvic pain (3.1%).

Please note that this information is not comprehensive. Please see the Full Prescribing Information, including BOXED WARNING, for BIJUVA at https://www.bijuva.com/pi.pdf.

ANNOVERA IMPORTANT SAFETY INFORMATION

ANNOVERA is a progestin/estrogen combination hormonal contraceptive (CHC) indicated for use by females of reproductive potential to prevent pregnancy. (Limitation of use: Not adequately evaluated in females with a BMI of > 29 kg/m2).

 

Cigarette smoking increases the risk of cardiovascular events from CHC use. This risk increases with age, particularly in females over 35 years of age, and with the number of cigarettes smoked. CHCs should not be used by females who are over 35 years of age and smoke.

Due to increased risks of serious side effects, ANNOVERA should not be used in females with certain medical conditions, including females who have a high risk of arterial or venous thrombotic diseases; who have or have had breast cancer or other estrogen- or progestin-sensitive cancer; who have liver tumors, acute hepatitis, severe cirrhosis, undiagnosed abnormal uterine bleeding, or hypersensitivity to any ingredients in ANNOVERA; who use certain Hepatitis C drug combinations; or who are pregnant or breastfeeding.

Risks from use of a CHC, like ANNOVERA, particularly in females with any condition listed above, include venous thrombotic events; cardiovascular events and cerebrovascular events such as stroke and myocardial infarction; liver disease; elevated liver enzymes with concomitant Hepatitis C treatment; hypertension; carbohydrate and lipid metabolic effects; headache; bleeding irregularities and amenorrhea.

ANNOVERA does not protect against HIV-infection (AIDS) and other sexually transmitted infections.

Please note that this information is not comprehensive. Please see the Full Prescribing Information, including the Boxed Warning, for ANNOVERA at www.annovera.com/pi.pdf.

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 agreement; 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 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.

Investor ContactNichol OchsnerVice President, Investor Relations561-961-1900, ext. 2088Nochsner@TherapeuticsMD.com

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