BOCA RATON, Fla.–(BUSINESS WIRE)–Apr. 17, 2019– TherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative, leading women’s healthcare company, today announced the commercial availability of BIJUVATM (estradiol and progesterone capsules, 1 mg/100 mg) in the United States. 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 proven balance of bio-identical estradiol to reduce moderate to severe hot flashes combined with bio-identical progesterone to reduce risks to the endometrium. Please see Important Safety Information, including Boxed Warning, for BIJUVA below.
Bio-identical refers to the estradiol and progesterone that are structurally identical to the hormones naturally circulating in a woman’s body.* 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.
“We are excited to offer women, healthcare providers and pharmacists an answer to their desire for bio-identical hormone therapy,” said Dr. Brian Bernick, Co-founder and Director of TherapeuticsMD. “TherapeuticsMD is proud to offer BIJUVA as an important new option to help manage the moderate to severe vasomotor symptoms experienced by up to 80% of menopausal women.”
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.
“The momentum we have seen early on with the payer community is encouraging and indicates recognition of the need for an FDA-approved combination bio-identical option,” said Dawn Halkuff, Chief Commercial Officer of TherapeuticsMD. “I am proud to work for a company committed to advancing women’s health with new treatments for women and their healthcare providers.”
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.
*The relevance of risks associated with the use of synthetic hormones compared to bio-identical hormones is not known, but cannot be excluded.
About Menopause and Vasomotor Symptoms (VMS)
Menopause is a natural life-stage transition for women that usually occurs at an average onset of 51 years of age.1 According to the United States Census Bureau, approximately 43 million women in the U.S. are of menopausal age (45-64 years) and women will spend greater than a third of their life in menopause with its associated morbidities.2
As the ovaries stop producing hormones, levels of circulating estrogen decrease, often causing vasomotor symptoms (VMS) (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 percent of women, and can be debilitating and last years after menopause.3 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 22 million 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 IMPORTANT SAFETY INFORMATION
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.