Officials with the FDA have approved TherapeuticsMD’s Bijuva (estradiol and progesterone) capsules, 1 mg/100 mg, the company announced Monday. According to TherapeuticsMD, Bijuva is the first and only FDA-approved bio-identical hormone therapy combination of estradiol and progesterone in a single, oral capsule for the treatment of moderate to severe vasomotor symptoms due to menopause in women with a uterus.
“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, in a prepared statement. “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. The primary safety endpoint was the incidence of endometrial hyperplasia with up to 12 months of treatment.
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.
“For the first time, we have a combination hormone therapy of bio-identical estradiol with bioidentical 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, in a prepared statement. “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 be available in the United States in 2019.
TherapeuticsMD Announces FDA Approval of TX-001HR: BIJUVA (Estradiol and Progesterone) Capsules for the Treatment of Moderate to Severe Vasomotor Symptoms Due to Menopause [news release]. Boca Raton, FL; October 29, 2018: TherapeuticsMD.