Posted from: Monday, December 10, 2018 - 11:11 AM - Present

Bijuva Approved to Treat Symptoms of Menopause

October 28, 2018 – The U.S. FDA has approved Bijuva™ (estradiol 1mg/progesterone 100mg) capsules, manufactured by TherapeuticsMD, to treat moderate to severe vasomotor symptoms due to menopause in women who have a uterus. The treatment combines two bioidentical hormones – hormones that are artificially created but chemically identical to those naturally produced in the body.

An estimated 11 million women reach menopause in the United States each year, and the average age of onset is 51 years old. Over 85% of these women experienced vasomotor symptoms, which include night sweats and hot flashes. The symptoms often are most intense for the first year or two of menopause, though they can persist for longer.

In a clinical trial, women treated with Bijuva experienced a significant reduction from baseline in frequency and severity of vasomotor symptoms compared to those treated with placebo. Bijuva also reduced risks to the endometrium associated with menopause. It is the first FDA-approved combined product to contain both a bioidentical estradiol and a bioidentical progesterone. Recommended dosing is one capsule taken with food each evening.

Bijuva carries a black box warning that estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia. The warning also indicates that, according to the Women’s Health Initiative (WHI), the use of estrogen plus progestin may increase the risk of stroke, deep vein thrombosis (DVT), pulmonary embolism (PE), myocardial infarction (MI), and invasive breast cancer. It may also increase the risk of probable dementia in postmenopausal women 65 years of age or older. According to the black box warning, estrogen-alone therapy may increase the risk of endometrial cancer in women who have a uterus and use unopposed estrogens. Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia. According to the WHI, it may increase the risk of stroke and DVT. Estrogen-alone therapy may also increase the risk of probable dementia in postmenopausal women 65 years of age or older.

TherapeuticsMD plans to launch Bijuva during the second quarter of 2019. Pricing information has not yet been announced.

Last Updated Monday, January 21, 2019 - 08:17 AM.