FDA approves pill for hot flashes in menopausal women

October 30, 2018 by Marcia Heroux Pounds, Sun Sentinel

TherapeuticsMD announced Monday that its single-pill hormone therapy for menopausal hot flashes has been approved for marketing by the U.S. Food and Drug Administration.

The new drug, which combines estradiol (estrogen) and progesterone in an oral softgel capsule, has been named Bijuva, and is expected to be available in the United States by April or May, the Boca Raton, Fla., company said.

For , the approval means a new option for . Currently, who want bio-identical hormone therapy—molecularly identical to the hormones produced by a woman's body—have to take two pills.

For the company, it means further entrance into a multibillion-dollar market of menopausal health care for women.

Dr. James Liu, president of the North American Menopause Society and chairman of Obstetrics and Gynecology at University Hospitals Cleveland Medical Center, said this is the first FDA approval of a combination therapy "evaluated in a large, well-controlled, that has demonstrated both safety and efficacy for the treatment of moderate to severe hot flashes due to menopause.

"The approval of Bijuva represents an important, novel and effective treatment option for women," Liu said.

The FDA approved Bijuva's higher dosage of 1 milligram of estradiol and 100 milligrams of progesterone. TherapeuticsMD had also proposed a capsule with a lower dose of estradiol. The FDA "thought there was no reason for a lower dose," the company said.

In August, TherapeuticsMD began distributing Imvexxy, its new treatment for menopausal women who experience painful sex due to vaginal atrophy. Imvexxy was approved for marketing by the FDA in May.

Explore further: Painful sex? New treatment for menopausal women on its way to pharmacies

1 shares

Related Stories

Painful sex? New treatment for menopausal women on its way to pharmacies

August 17, 2018
For menopausal women who experience painful sex, a new treatment is on its way to pharmacies.

New natural estrogen-progesterone capsule reduces postmenopausal hot flashes

April 3, 2017
A natural, or bioidentical, combined estradiol-progesterone capsule (TX-001HR) significantly decreases the frequency and severity of moderate to severe hot flashes in postmenopausal women, the Replenish study finds. Results ...

Do alternative therapies work to treat menopausal symptoms?

October 17, 2018
Of the 80 per cent of women who develop symptoms during menopause, many will experiment with complementary and alternative medicines (CAMs) as well as lifestyle changes to treat their symptoms, said Tami Shandro, a University ...

Hormone therapy may lead to improved cognitive function

May 30, 2018
Hormones affect just about everything that goes on in a woman's body, from reproductive function and sexual libido to weight gain and overall mood. A new study shows how, in the right dosage and combination, hormones also ...

Artery hardening and thickness not affected by stopping hormone therapy

July 18, 2018
Heart disease is still the number one killer of US women, and hormone therapy remains a top treatment for menopause symptoms. A new study connects these two facts to demonstrate little effect of hormone therapy on artery ...

Study finds hormone therapy improves sleep quality for recently menopausal women

August 29, 2017
For many women, the side effects of menopause don't call it a day when they do.

Recommended for you

Human Cell Atlas study reveals maternal immune system modifications in early pregnancy

November 14, 2018
The first Human Cell Atlas study of early pregnancy in humans has shown how the function of the maternal immune system is affected by cells from the developing placenta. Researchers from the Wellcome Sanger Institute, Newcastle ...

Soy formula feeding during infancy associated with severe menstrual pain in adulthood

November 9, 2018
New research suggests that infant girls fed soy formula are more likely to develop severe menstrual pain as young adults. The finding adds to the growing body of literature that suggests exposure to soy formula during early ...

A major role for a small organ in the immune response during pregnancy

November 9, 2018
The immune system of a pregnant woman is altered during pregnancy, but not in the way previously believed, according to results from a study at Linköping University, Sweden. This study, published in the Journal of Allergy ...

Mailed HPV tests can help find women at-risk for cervical cancer, study finds

November 7, 2018
University of North Carolina Lineberger Comprehensive Cancer Center researchers have found that mailing self-collection kits to test for high-risk human papillomavirus infection has the potential to boost cervical cancer ...

Women who give birth to boys much more likely to have postnatal depression

November 6, 2018
A University of Kent study into postnatal depression (PND) found the odds of developing this condition increased by 79% when mothers had baby boys compared to baby girls.

New study takes first step toward treating endometriosis

November 1, 2018
Researchers at Northwestern Medicine have taken the first step in bioengineering the human uterus to treat endometriosis, uterine-factor infertility and endometrial cancer.

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.