TherapeuticsMD Inc (NASDAQ:TXMD) recently received approval for its BIJUVA™ Capsules of 1mg/100 mg from the United States Food and Drug Administration (FDA). BIJUVA™ is first and the only bio-identical combination of hormone therapy of progesterone and estradiol approved by FDA. It is the only single oral capsule treatment addressing moderate to severe symptoms of vasomotor in women during the menopause phase.
FDA approval opens up new opportunity for menopausal women
Vasomotor symptoms cause hot flushes and flashes in women with a uterus. TXMD is a healthcare company dedicated to developing innovative treatments for women. According to the director and Co-Founder of TXMD, Dr. Brian Bernick,”The approval of BIJUVA represents an important and new opportunity for menopausal women suffering from moderate to severe vasomotor symptoms. Menopausal women and their health care providers have been seeking bio-identical combination therapies for many years without an FDA-approved option.”
He further added that BIJUVA is the only bio-identical hormones’ combination to receive approval from FDA. It offers a proven bio-identical estradiol balance to reduce moderate to severe hot flushes/flashes. The combination includes bio-identical progesterone for reducing endometrium risks. According to the CEO and Co-founder at TXMD, Robert Finizio the approval from FDA is a landmark achievement for the company as it continues to develop a full portfolio of products for women for all their life’s stages.
Finizio stated further that BIJUVA treats an important requirement for bio-identical hormone therapy and offers women, their healthcare givers, and pharmacists a proven product with bio-identical combination and insurance coverage assurance. FDA approved the TXMD product based on the company’s clinical development program BIJUVA that includes Phase III Replenish Trial.
The trial evaluates the efficacy and safety of BIJUVA in postmenopausal uterus-bearing women who are generally healthy but suffer from moderate to severe hot flashes.
Around 80% US women in menopausal age suffer from hot flashes
According to the U.S. Census Bureau, around 43 million women in the United States belong to menopausal age between 45 and 64. The statistics say that around 80% of all these menopausal women suffer from night sweats and hot flashes symptoms. Analysts consider BIJUVA as the potential blockbuster as it addresses these issues of women successfully.