“We are excited to report results from the REPLENISH Phase 3 trial for BIJUVA that show improvements in several sleep parameters, including sleep disturbances, in menopausal women with moderate to severe vasomotor symptoms taking BIJUVA as compared to placebo. In addition, we will present data for BIJUVA showing a consistency of effect for improvements in the frequency and severity of vasomotor symptoms in different subpopulations, regardless of age or body mass index,” said
Additionally, two oral presentations will review the growth of the vulvar vaginal atrophy (VVA) market and patient acceptability data, including patient satisfaction and preference, for IMVEXXY.
The posters and presentations will be made available on the Investors & Media section of the company’s website at www.therapeuticsmd.com.
Oral Presentations
Date:
Time:
Title: Growth of the Vulvar Vaginal Atrophy (VVA) Therapy Market
Date:
Time:
Title: Postmenopausal Women Using a Softgel Estradiol Vaginal Insert to Treat Moderate-to-Severe Dyspareunia were Satisfied with it and Preferred it over a Previous Therapy
Posters
Date:
Time:
Title: Uterine Bleeding Rates with Hormone Therapies in Menopausal Women with Vasomotor Symptoms (Poster P-55)
Title: Baseline Estradiol Levels in Postmenopausal Women (Poster P-11)
Title: Nonsmokers May Benefit from Lower Doses of an Oral 17β-Estradiol/Progesterone Capsule — Data from the REPLENISH Trial (Poster P-12)
Title: Oral 17β-Estradiol/Progesterone (E2/P4) Improved Sleep Outcomes in the REPLENISH Trial (Poster P-31)
Title: E2/P4 Capsules Effectively Treat Vasomotor Symptoms Irrespective of Age and BMI (Poster P-6)
Please see the Full Prescribing Information, including indication and Boxed WARNING, for IMVEXXY and BIJUVA as follows:
- IMVEXXY (estradiol vaginal inserts) at https://imvexxy.com/pi.pdf
- BIJUVA (estradiol and progesterone) capsules at https://www.bijuva.com/pi.pdf
INDICATION
IMVEXXY (estradiol vaginal inserts) is an estrogen indicated for the treatment of moderate-to- severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause.
IMPORTANT SAFETY INFORMATION
WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER and PROBABLE DEMENTIA
See full prescribing information for complete boxed warning.
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 Women’s Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT)
- The WHI Memory Study (WHIMS) estrogen-alone ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older
Estrogen Plus Progestin Therapy
- Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia
- The WHI estrogen plus progestin substudy reported increased risks of stroke, DVT, pulmonary embolism (PE) and myocardial infarction (MI)
- The WHI estrogen plus progestin substudy reported increased risks of invasive breast cancer
- The WHIMS estrogen plus progestin ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older
CONTRAINDICATIONS
- IMVEXXY is contraindicated in women with any of the following conditions: undiagnosed abnormal genital bleeding; known, suspected, or history of breast cancer; known or suspected estrogen-dependent neoplasia; active DVT, PE, or history of these conditions; active arterial thromboembolic disease or a history of these conditions; known anaphylactic reaction or angioedema to IMVEXXY; known liver impairment or disease; known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders.
WARNINGS AND PRECAUTIONS
- IMVEXXY is intended only for vaginal administration. Systemic absorption may occur with the use of IMVEXXY.
- The use of estrogen-alone and estrogen plus progestin therapy has been reported to result in an increase in abnormal mammograms requiring further evaluation.
- 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.
- Other warnings include: gallbladder disease; severe hypercalcemia, loss of vision, severe hypertriglyceridemia or cholestatic jaundice.
- Estrogen therapy may cause an exacerbation of asthma, diabetes mellitus, epilepsy, migraine, porphyria, systemic lupus erythematosus, and hepatic hemangiomas and should be used with caution in women with these conditions.
- Women on thyroid replacement therapy should have their thyroid function monitored.
ADVERSE REACTIONS
- The most common adverse reaction with IMVEXXY (incidence ≥ 3 percent) and greater than placebo was headache.
Please note that this information is not comprehensive. Please see/click here for the Full Prescribing Information, including the Boxed Warning.
INDICATION
BIJUVA is a combination of estradiol and progesterone indicated in a woman with a uterus for the treatment of moderate to severe vasomotor symptoms due to menopause.
IMPORTANT SAFETY INFORMATION
WARNING: CARDIOVASCULAR DISORDERS, BREAST CANCER, ENDOMETRIAL CANCER, and PROBABLE DEMENTIA
See full prescribing information for complete boxed warning.
Estrogen Plus Progestin Therapy
- Estrogenplus 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 or 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 AND 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 and 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 at www.BIJUVA.com.
About
Forward-Looking Statements
This press release by
View source version on businesswire.com: https://www.businesswire.com/news/home/20190924005148/en/
Source:
Investor Contact
Nichol Ochsner,
Vice President Investor Relations
561-961-1900, ext. 2088
Nochsner@TherapeuticsMD.com