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
“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
BIJUVA is the first and only
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.
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.
Time and Location:
Title: Combined Bioidentical Estradiol and Progesterone Capsules Improved Quality of Sleep in Postmenopausal Women with Vasomotor Symptoms
Authors: N Santoro, G Constantine, R Kagan, S Graham, B Bernick, S Mirkin
Time and Location: 1:00-3:00
Title: Bioidentical Estradiol and Progesterone Improved Hot Flushes, Night Sweats and Sweating
Authors: J Liu, AM Kaunitz, JA Simon, B Bernick, S Mirkin
Time and Location:
Title: Predictors of Vaginal/Uterine Bleeding with Oral TX-001HR (Estrogen and
Progesterone) Capsules Taken for Menopausal Vasomotor Symptoms
Authors: G Constantine, SR Goldstein, JH Pickar, S Graham, B Bernick, S Mirkin
Time and Location:
Title:A Novel 1-Year Contraceptive Vaginal System DeliveringSegesterone Acetate and EthinylEstradiol: Effects on Lipids and other Hepatic Proteins
Authors: DF Archer, MA Thomas, R Sitruk-Ware, J Liu, B Bernick, S Mirkin, R Merkatz, N Kumar, DL Blithe
Time and Location:
Title:Nonsmokers Benefit from Lower Doses of an Estradiol/Progesterone Combination: Results of the REPLENISH Trial
Authors: G Constantine, S Graham, B Bernick, S Mirkin
Time and Location:
Title: Low Systemic Levels of Segesterone Acetate are Required to Inhibit Ovulation in Women
Authors: 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
- 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.
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%).
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.
This press release by
Vice President, Investor Relations
561-961-1900, ext. 2088