FDA approves first ever bioidentical hormone combo for treatment of menopausal symptoms

The U.S. Food and Drug Administration (FDA) approved TherapeuticsMD’s oral hormone combo, BIJUVA™ (estradiol and progesterone) for relief from menopause symptoms such as mild to moderate hot flashes, sleep disturbances, and night sweats.

Bijuva is the first and only FDA-approved bio-identical* hormone therapy combination of estradiol and progesterone in a single, oral capsule available for treatment of distressing hot flashes or flushes in menopausal women with a uterus.

Brian Bernick, Co-Founder and Director of TherapeuticsMD said in a press release, “The approval of BIJUVA represents an important and new opportunity for menopausal women suffering from moderate to severe vasomotor symptoms. Menopausal women and their health care providers have been seeking bio-identical combination therapies for many years without an FDA-approved option.”

This is also an important milestone for TherapeuticsMD raking its third approval from FDA this year following Imvexxy, a bioidentical estradiol vaginal insert, and Annovera, a hormonal birth control ring.

The approval is based on results of a large 12 months, well-controlled, multicenter, randomized phase III Replenish clinical trial that has demonstrated both safety and efficacy of the drug in the treatment of moderate to severe hot flashes due to menopause. The study results were published July 2018 in the journal Obstetrics & Gynecology.

The primary efficacy end-point studied was a change in frequency and severity of hot flashes from baseline at weeks 4 and 12 weeks as compared to placebo in the vasomotor symptoms substudy group. Secondary endpoints were responder analyses and menopause-specific quality of life (MENQOL) questionnaire.

The primary safety endpoint of endometrial hyperplasia was evaluated in the entire study population at the end of the study period of 12 months.

One thousand eight hundred forty-five women (1,255 were eligible for the endometrial safety population; 726 comprised the vasomotor symptoms substudy) were randomized over a period of nearly two years to receive either daily estradiol (mg)-progesterone (mg) (1/100, 0.5/100, 0.5/50, or 0.25/50), or placebo. The average age was 55 years and BMI 27.

No endometrial hyperplasia was observed at the end of 12 months, while single dose estradiol-progesterone capsule (1 mg/100 or 0.5 mg/100 estradiol and progesterone) provided significant relief from vasomotor symptoms and improvement in the MENQOL domain was observed. Women reported a reduction in hot flashes as early as four weeks of treatment.

The researchers concluded, “This estradiol-progesterone formulation may represent a new option, using naturally occurring hormones, for the estimated 3 million women using nonregulatory-approved, compounded hormone therapy.” Although, currently there is no evidence that bio-identical hormones are superior to synthetic hormones.

Dr. James Liu, M.D., President of the North American Menopause Society and Chairman of the Department of Obstetrics and Gynecology, UH Cleveland Medical Center said, “The approval of BIJUVA represents an important, novel and effective treatment option for women and their healthcare providers to manage the vasomotor symptoms of menopause.”

Bijuva is expected to hit the US markets in the second quarter of 2019. According to the U.S. Census Bureau, about 43 million American women are of the menopausal age of between 45 and 64, and some 80 percent of all menopausal women experience symptoms like hot flashes and night sweats.

The most common side effects are breast tenderness, vaginal discharge and spotting, headache, and pelvic pain.

Bijuva comes with a boxed warning for cardiovascular disorders, breast cancer, endometrial cancer, and probable dementia.

FDA press release

TherapeuticsMD press release

REPLENISH Trial

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