Bijuva (TherapeuticsMD, Inc, Bocan Raton, Florida) is the first and sole FDA-approved combination of bio-identical hormones for moderate to severe hot flashes caused by menopause. The new product, with bio-identical estradiol to reduce hot flashes and bio-identical progesterone to reduce endometrial risks, is expected to be available in the U.S. after March 2019.
According to the United States Census Bureau, approximately 43 million U.S. women are of menopausal age (45–64 years). For more than one third of their lives, they will have symptoms such as hot flashes, sleep and mood disturbances, and genitourinary problems. Eighty percent of women experience hot flashes, which are often incapacitating and continue for years after menopause.
Bijuva, a non-synthetic, softgel, oral capsule, will provide women with an alternative to the currently available synthetic hormones, the separate bio-identical estrogen and progesterone products that are used together although not approved for such use, and the unapproved compounded bio-identical hormone products.
In a large, randomized clinical trial, there was 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. Common adverse reactions included breast tenderness, headache, vaginal bleeding, vaginal discharge and pelvic pain.
Source: Drugs.com, October 29, 2018