Nelson Vergel
Founder, ExcelMale.com
This treatment has been available via compounding pharmacies for years.
The FDA has approved the first bioidentical hormone therapy combination of estradiol and progesterone for moderate to severe vasomotor symptoms associated with menopause, TherapeuticsMD announced in a press release.
The approval of the bioidentical estradiol and progesterone capsules (Bijuva), follows results from the phase 3 REPLENISH trial, first presented at the Endocrine Society annual meeting in April 2017 and reported by Endocrine Today, which demonstrated that a combination of 17beta-estradiol and progesterone appears to be safe and effective for reducing hot flash frequency and severity in menopausal women with a uterus.
“The approval of Bijuva represents an important and new opportunity for menopausal women suffering from moderate to severe vasomotor symptoms,” Brian Bernick, co-founder and director of TherapeuticsMD, said in the release. “Menopausal women and their health care providers have been seeking bioidentical combination therapies for many years without an FDA-approved option.”
FDA approves bioidentical hormone therapy for menopausal hot flashes
The FDA has approved the first bioidentical hormone therapy combination of estradiol and progesterone for moderate to severe vasomotor symptoms associated with menopause, TherapeuticsMD announced in a press release.
The approval of the bioidentical estradiol and progesterone capsules (Bijuva), follows results from the phase 3 REPLENISH trial, first presented at the Endocrine Society annual meeting in April 2017 and reported by Endocrine Today, which demonstrated that a combination of 17beta-estradiol and progesterone appears to be safe and effective for reducing hot flash frequency and severity in menopausal women with a uterus.
“The approval of Bijuva represents an important and new opportunity for menopausal women suffering from moderate to severe vasomotor symptoms,” Brian Bernick, co-founder and director of TherapeuticsMD, said in the release. “Menopausal women and their health care providers have been seeking bioidentical combination therapies for many years without an FDA-approved option.”
FDA approves bioidentical hormone therapy for menopausal hot flashes
