Bijuva Proven Bioidentical Hormone Therapy for Menopause Hot Flashes
The FDA has approved Bijuva (estradiol and progesterone capsules, 1 mg/100 mg) as the first and only FDA approved bioidentical hormone therapy menopause combination in a single oral capsule. Developed by TherapeuticsMD, Bijuva is approved for the treatment of moderate to severe vasomotor symptoms, commonly known as hot flashes, in postmenopausal women with a uterus. According to the Mayo Clinic, hot flashes affect the majority of menopausal women and can significantly disrupt sleep, daily function, and quality of life.
Why This Approval Matters for Menopausal Women
Menopausal women and their healthcare providers have sought a bioidentical hormone therapy menopause combination product for years, but until Bijuva, no FDA approved option existed. Compounding pharmacies have long provided bioidentical hormone combinations, but without the validation of a large controlled clinical trial and without insurance coverage. As Kelly Selby, a compounding pharmacist and pharmacy owner, noted, the approval finally supports the science of bioidentical estradiol and progesterone while providing women with a commercially available, insurance eligible option.
Dr. Brian Bernick, co-founder of TherapeuticsMD, described the approval as an important new opportunity for menopausal women suffering from moderate to severe vasomotor symptoms, offering a proven balance of bioidentical estradiol to reduce hot flashes combined with bioidentical progesterone to protect the endometrium.
How Bijuva Works
Bijuva combines two bioidentical hormones in a single capsule taken orally. Estradiol addresses the vasomotor symptoms of menopause by supplementing declining estrogen levels. Progesterone is included specifically to reduce the risks to the endometrium that estrogen alone can pose when used in women with a uterus. This combination makes bioidentical hormone therapy menopause treatment both effective and safer for this patient population compared to estrogen only approaches.
3 Proven Results From the Replenish Trial
1. Statistically Significant Reduction in Hot Flash Frequency and Severity
The FDA approval is based on the pivotal Phase III Replenish Trial, which evaluated Bijuva in generally healthy postmenopausal women with a uterus. The co-primary efficacy endpoints were changes from baseline in the number and severity of hot flashes at weeks four and twelve compared to placebo. Bijuva demonstrated a statistically significant reduction in both the frequency and severity of hot flashes compared to placebo, confirming its efficacy as a bioidentical hormone therapy menopause treatment.
2. Endometrial Safety Was Demonstrated Over 12 Months
The primary safety endpoint of the Replenish Trial was the incidence of endometrial hyperplasia with up to 12 months of treatment. Bijuva met this endpoint, demonstrating that the inclusion of progesterone effectively reduces the endometrial risks associated with estrogen therapy. Results were published in the journal Obstetrics and Gynecology.
3. First Large Randomized Trial to Validate Combined Bioidentical Hormones
As Dr. James Liu, president of the North American Menopause Society and chairman of obstetrics and gynecology at UH Cleveland Medical Center, stated, this is the first combined hormone therapy of bioidentical estradiol with bioidentical progesterone evaluated in a large, well controlled, randomized clinical trial. That distinction matters because it separates Bijuva from compounded preparations that lacked clinical trial validation and establishes a new standard for bioidentical hormone therapy menopause research and practice.
For many women, the availability of an FDA approved bioidentical hormone therapy menopause option also removes the financial barrier that previously made compounded alternatives inaccessible. Insurance coverage for Bijuva means more patients can access clinically validated treatment without relying on out-of-pocket compounding costs.
What Comes Next
TherapeuticsMD indicated that Bijuva would be available in the United States in the second quarter of 2019. The approval reflects the company’s broader strategy of building a full portfolio of products addressing women’s health across all life stages.
FOMAT conducts Phase I through Phase IV clinical research across a national network of investigator sites throughout the United States. To learn more about active women’s health and endocrinology studies, visit our patient active studies page.