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

Abstract

CDC: Meeting the Challenges of Measuring and Preventing Maternal Mortality in the United States

Women in the United States are more likely to die from childbirth or pregnancy-related causes than other women in high-income countries. More evidence is needed to understand the actual causes of death better, but research suggests that half of these deaths may be preventable. Racial disparities persist. The risk of pregnancy-related deaths for black women is three to four times higher than those of white women.

Watch this session of Grand Rounds to learn about efforts to analyze and prevent future deaths. Hear our speakers discuss the effects maternal deaths have on the family and on the community. You will also learn about how CDC has collaborated and intervened through public-private partnership efforts to prevent deaths associated with childbirth and pregnancy.

About CDC Public Health Grand Rounds

CDC Public Health Grand Rounds is a monthly scientific presentation featuring the important work that CDC is doing in the United States and around the world to protect people and save lives.  Experts discuss major public health issues, key challenges, cutting-edge scientific evidence, potential solutions, and recent developments. Each session is the result of a rigorous process which takes months to prepare. This attention to detail ensures that our audiences receive up-to-date, scientifically accurate, and usable information. Grand Rounds welcomes clinicians, researchers, students of public health, medicine and nursing, and the public that we serve to attend in person or watch the live webcast.

At least one year is the ideal pregnancy spacing time for the health of mother and baby

  

One to one and a half year is the ideal spacing time between pregnancies according to researchers from the University of British Columbia (B.C.) and the Harvard T.H. Chan School of Public Health.

The study found an increased risk of premature births, maternal morbidity and mortality, and adverse neonatal outcome following an interpregnancy interval of fewer than 12 months in women of all ages. However, women who were 35 or more were at increased risks of maternal mortality or severe morbidity, while women aged 20 to 34 years were at increased risk of preterm labor and adverse fetal and infant outcomes.

In this large cohort study published online October 29 in JAMA Internal Medicine, the researchers looked at data from 148,544 pregnancies in B.C. to examine the relationship between interpregnancy interval and adverse pregnancy. The data was gathered from billing codes, hospitalization data, birth records, prescription data for infertility information, and census records for a period of 10 years (2004 to 2014).

The study is the most extensive and in-depth evaluation of the relationship between pregnancy spacing and maternal age. Currently, it is unknown whether older women face the same risk as younger women because of a shorter interpregnancy interval.

Women aged 35 and more who conceived within six months of a previous birth, faced 1.2 percent risk (12 cases per 1,000 pregnancies) of maternal mortality or severe morbidity (mechanical ventilation, blood transfusion >3 U, intensive care unit admission, and organ failure). Keeping an interpregnancy interval of 18 months, however, reduced the risk to 0.5 percent (five cases per 1,000 pregnancies).

For younger women, who conceived within six months of last childbirth, the researchers found an 8.5 percent risk (85 cases per 1,000 pregnancies) of spontaneous preterm birth, but the risk dropped to 3.7 percent (37 cases per 1,000 pregnancies) if the women waited 18 months before the next conception. 

Among older women, the risk of spontaneous preterm labor was about six percent (60 cases per 1,000 pregnancies) at the six-month interval, compared to 3.4 percent (34 cases per 1,000 pregnancies) at the 18-month interval.

“Our study found increased risks to both mother and infant when pregnancies are closely spaced, including for women older than 35,” said the study’s lead author Laura Schummers in a University of British Columbia news release. Dr. Schummers is a postdoctoral fellow in the UBC department of family practice who carried out the study as part of her dissertation at the Harvard T.H. Chan School of Public Health. “The findings for older women are particularly important, as older women tend to more closely space their pregnancies and often do so intentionally,” she further added. 

Senior author Dr. Wendy Norman, associate professor in the UBC department of family practice, said these findings of a shorter optimal interval are encouraging for women over 35 who are planning their families.

“Older mothers for the first time have excellent evidence to guide the spacing of their children,” said Norman. “Achieving that optimal one-year interval should be doable for many women and is clearly worthwhile to reduce complication risks.”

JAMA Internal Medicine Full Text

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