FDA approves first of its kind hormone therapy for menopausal symptoms

Hot flashes are common in women who are advancing towards perimenopause, year near to menopause. But there are many sever to moderate symptoms associated with it. The most well-known of all is the vasomotor symptom.

The US Food and Drug Administration has now approved first of its kind capsule "BIJUVA"which contains progesterone and estradiol. It is the first bio-identical hormone therapy combination that has been approved by the FDA. The approval was announced by TherapeuticMD, manufacturer of BIJUVA.

“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 FDA-approved option,” said Dr. Brian Bernick, Co-Founder, and Director of TherapeuticsMD. “BIJUVA is the first and only FDA-approved combination of bio-identical hormones, offering a proven balance of bio-identical estradiol to reduce moderate to severe hot flashes combined with bio-identical progesterone to reduce the risks to the endometrium.”

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. Consistent with FDA guidance, the co-primary efficacy endpoints in the Replenish Trial were the change from baseline in the number and severity of hot flashes at weeks 4 and 12 as compared to placebo.

BIJUVA demonstrated a statistically significant reduction from baseline in both the frequency and severity of hot flashes compared to placebo while reducing the risks to the endometrium. The most common adverse reactions (≥3 percent) were breast tenderness, headache, vaginal bleeding, vaginal discharge, and pelvic pain. Additionally, there were no clinically significant changes in lipid, coagulation or glucose parameters as compared to placebo. There were no unexpected safety signals. The results of the trial were published in the journal Obstetrics & Gynecology.

“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. James Liu, M.D., President of the North American Menopause Society and Chairman of the Department of Obstetrics and Gynecology, UH Cleveland Medical Center. “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 will be available in the U.S from the second quarter of 2019.