TherapeuticsMD Announces FDA Approval BIJUVA for Moderate to Severe Hot Flashes Due to Menopause

The FDA has just approved BIJUVA, an oral hormone therapy for moderate to severe vasomotor symptoms (also known as hot flashes) due to menopause. This is the first and only FDA-approved bio-identical hormone therapy combination of estradiol and progesterone in a single capsule.

Menopause is a naturally occurring transition for women with an average onset age of 51 years old. During menopause the ovaries stop producing hormones leading to a decrease in estrogen levels, which often causes vasomotor symptoms. These includes hot flashes, night sweats, sleep and mood disturbances. Hot flashes and night sweats are the most common symptoms and effect up to 80% of menopausal women.

Bijuva comes in the form of an oral softgel capsule and contains a combination of bio-identical estradiol and progesterone. Bio-identical means that these hormones are molecularly identical to the ones that naturally occur in a woman’s body. The Phase III Replenish trial showed that Bijuva lead to 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.

Dr. Robin Kroll served as a principal investigator for the Bijuvia clinical trial.  She is committed to ensuring that each woman seen in our office fully understands her individual risk and benefit profile for the use of hormone therapy. Bijuvia adds an important option for women suffering from vasomotor symptoms.  All three of our board-certified Gynecologists are experts in menopause management and want to ensure that women receive correct evidence-based information so that they can make an informed choice. 

Bijuva is expected to be available in pharmacies in spring of 2019.