22 April 2019 - - US-based women's healthcare company TherapeuticsMD, Inc. (NASDAQ: TXMD) has made Bijuva (estradiol and progesterone capsules, 1 mg/100 mg) commercially available in the United States, the company said.

Bijuva is the first and only FDA-approved bio-identical hormone therapy combination of estradiol and progesterone in a single, oral daily capsule for the treatment of moderate-to-severe vasomotor symptoms (commonly known as hot flashes or flushes) due to menopause in women with a uterus.

Bijuva offers a balance of bio-identical estradiol to reduce moderate to severe hot flashes combined with bio-identical progesterone to reduce risks to the endometrium.

Bio-identical refers to the estradiol and progesterone that are structurally identical to the hormones naturally circulating in a woman's body.

According to the company, the commercial availability of Bijuva fills an unmet need by offering an FDA-approved bio-identical alternative to marketed synthetic hormone combinations and the combined use of separate estrogen and progesterone products.

As of April 19, 2019, three of the top ten commercial payers Express Scripts, Anthem and Aetna will be adjudicating Bijuva in the commercial health insurance channel for the majority of their formulary designs.

TherapeuticsMD plans to hold an Investor Day in New York on Monday, June 10, 2019 to highlight its commercial strategy for its product portfolio, including BIJUVA.

Menopause is a natural life-stage transition for women that usually occurs at an average onset of 51 years of age.

According to the United States Census Bureau, approximately 43m women in the US are of menopausal age (45-64 years) and women will spend greater than a third of their life in menopause with its associated morbidities.

As the ovaries stop producing hormones, levels of circulating estrogen decrease, often causing vasomotor symptoms (commonly known as hot flashes or flushes), as well as sleep and mood disturbances and genitourinary problems.

Hot flashes (including night sweats) are the most common symptoms, occurring in up to 80% of women, and can be debilitating and last years after menopause.

Despite living with these troublesome symptoms, many women do not seek treatment.

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 (commonly known as hot flashes or flushes) due to menopause in women with a uterus.

There are an estimated 16 to 22m total prescriptions of the FDA-approved separate bio-identical estradiol and progesterone and compounded bio-identical estrogen and progesterone products filled annually in the US.4

Bijuva is a combination of an estrogen and progesterone indicated in a woman with a uterus for the treatment of moderate to severe vasomotor symptoms due to menopause.