TherapeuticsMD, Inc., an innovative pharmaceutical company, committed to advance women’s healthcare, recently announced that its BIJUVA™ (estradiol and progesterone) capsules have been approved by the United States Food and Drug Administration (FDA). BIJUVA is the first oral capsule that has been approved by the FDA to treat vasomotor symptoms or hot flashes that commonly occur in menopausal women. BIJUVA is also the only combination of estradiol and progesterone hormone therapy capsule that has received such an approval.
Dr. Brian Bernick, Director and Co-Founder of TherapeuticsMD has been quoted to say that the approval of BIJUVA presents a new opportunity for women suffering from severe to moderate vasomotor symptoms. He added that for many years, healthcare providers for menopausal women as well as the women themselves had been looking for bio-identical combination therapies but had none that were approved by the FDA. BIJUVA is the first FDA approved amalgamation of bio-identical hormones that has been designed to offer a balance of bio-identical estradiol and progesterone. While estradiol reduces hot flashes, progesterone reduces the risk to the endometrium.
Robert Finizio, Co-Founder and CEO, TherapeuticsMD, has reportedly said that the FDA approval of BIJUVA is a significant milestone for TherapeuticsMD as it marks the company’s continuance towards offering a portfolio of products that are suitable for women at every stage of their lives. He added that BIJUVA addresses an important demand for hormone therapy that has been highlighted by women, pharmacists and healthcare providers and is a bio-identical combination drug that can be covered by a patient’s insurance.
The Sun Sentinel reports that according to a regulatory filing by TherapeuticsMD, the symptoms of menopause affects nearly 30 million women in the USA and presents a market opportunity of more than $25 billion for BIJUVA.
Dr. James Liu, President, North American Menopause Society has been quoted to say that for the first time there is a combination hormone therapy available that has been evaluated in an extensive, randomized, well-controlled clinical trial and has established efficacy and safety for the treatment of hot flashes.