BIJUVA is the First and Only FDA-Approved Hormone Therapy of Bio-Identical Estradiol in Combination with Bio-Identical Progesterone
BIJUVA is Expected to Be Available in Pharmacies in the Second Quarter of 2019
TherapeuticsMD Will Host a Conference Call on
“The approval of BIJUVA represents an important and new opportunity for
menopausal women suffering from moderate to severe vasomotor symptoms.
Menopausal women and their healthcare providers have been seeking
bio-identical combination therapies for many years without an
“This is an important milestone for
The approval is based on the BIJUVA clinical development program that
included the pivotal Phase III Replenish Trial. This trial evaluated the
safety and efficacy of BIJUVA in generally healthy, postmenopausal women
with a uterus for the treatment of moderate to severe hot flashes.
“For the first time, we have a combination hormone therapy of
bio-identical estradiol with bio-identical progesterone evaluated in a
large, well-controlled, randomized clinical trial that has demonstrated
both safety and efficacy for the treatment of moderate to severe hot
flashes due to menopause,” said Dr.
“The approval of BIJUVA finally supports the science of combination
bio-identical estradiol and progesterone,” said
Conference Call and Webcast Information
|Date: Monday, October 29, 2018|
|Time: 8:30 A.M. ET|
|Telephone Access (US): 866-665-9531|
|Telephone Access (International): 724-987-6977|
|Access Code for All Callers: 5669703|
Additionally, a live webcast and audio archive for the event may be
accessed on the homepage or from the “Investors & Media” section of the
About Menopause and Vasomotor Symptoms (VMS)
Menopause is a natural life-stage transition for women that usually
occurs at an average onset of 51 years of age.3 According to
As the ovaries stop producing hormones, levels of circulating estrogen decrease, often causing vasomotor symptoms (VMS) (commonly known as hot flashes or flushes), as well as sleep and mood disturbances and genitourinary problems. Hot flashes (including night sweats) are the most common symptoms, occurring in up to 80 percent of women, and can be debilitating and last years after menopause.5 Despite living with these troublesome symptoms, many women do not seek treatment.
BIJUVA is a novel combination of bio-identical estradiol and
bio-identical progesterone approved for the treatment of moderate to
severe vasomotor symptoms associated with menopause in women with a
uterus in a once daily softgel capsule taken orally. Bio-identical
refers to estradiol and progesterone that are molecularly identical to
the hormones circulating naturally in the woman’s body. There is no
evidence that bio-identical hormones are safer or more effective than
synthetic hormones. BIJUVA is the first and only bio-identical estradiol
and bio-identical progesterone product offering women an alternative to
* “Bio-identical” refers to estradiol and progesterone that are molecularly identical to the hormones produced naturally in the woman’s body. There is no evidence that bio-identical hormones are safer or more effective than synthetic hormones.
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.
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
• 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
• 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
- 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 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%).
This press release by
12003 FDA Draft Guidance for Industry Estrogen and Estrogen/Progestin Drug Products to Treat Vasomotor Symptoms and Vulvar and Vaginal Atrophy Symptoms – Recommendations for Clinical Evaluation http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm071643.pdf.
2Lobo RA, Archer DF, Kagan R, Kaunitz AM, Constantine GD, Pickar JH, Graham S, Bernick B, Mirkin S. A 17β-Estradiol-Progesterone Oral Capsule for Vasomotor Symptoms in Postmenopausal Women: A Randomized Controlled Trial. Obstet Gynecol 2018;132:161-170.
3NAMS “Overview of Menopause” 2010.
5Woods NF, Mitchell ES. Symptoms during the perimenopause: prevalence, severity, trajectory, and significance in women’s lives. Am J Med. 2005;118(suppl 12B):14–24.
6Consensus estimate based on Symphony Health Solutions PHAST
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