TherapeuticsMD Announces FDA Approval of TX-001HR: BIJUVA™ (Estradiol and Progesterone) Capsules for the Treatment of Moderate to Severe Vasomotor Symptoms Due to Menopause

BOCA RATON, Fla.--TherapeuticsMD, Inc. (NASDAQ:TXMD), an innovative women’s healthcare company, today announced that the United States Food and Drug Administration (FDA) has approved BIJUVA™ (estradiol and progesterone) capsules, 1 mg/100 mg, 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.

“The approval of BIJUVA represents an important and new opportunity for menopausal women suffering from moderate to severe vasomotor symptoms. Menopausal women and their healthcare providers have been seeking bio-identical combination therapies for many years without an FDA-approved option,” said Dr. Brian Bernick, Co-Founder and Director of TherapeuticsMD. “BIJUVA is the first and only FDA-approved combination of bio-identical hormones, offering a proven balance of bio-identical estradiol to reduce moderate to severe hot flashes combined with bio-identical progesterone to reduce the risks to the endometrium.”

“This is an important milestone for TherapeuticsMD as we continue to build towards offering a full portfolio of products to women at all stages of their lives,” said Robert Finizio, TherapeuticsMD CEO and Co-Founder. “BIJUVA addresses a significant demand for bio-identical hormone therapy and provides women, their healthcare providers and pharmacists with a proven bio-identical combination product that can be covered by their insurance.”

The approval is based on the BIJUVA clinical development program that included the pivotal Phase III Replenish Trial. This trial evaluated the safety and efficacy of BIJUVA in generally healthy, postmenopausal women with a uterus for the treatment of moderate to severe hot flashes. Consistent with FDA guidance, the co-primary efficacy endpoints in the Replenish Trial were the change from baseline in the number and severity of hot flashes at weeks 4 and 12 as compared to placebo.1 The primary safety endpoint was the incidence of endometrial hyperplasia with up to 12 months of treatment. BIJUVA demonstrated a statistically significant reduction from baseline in both the frequency and severity of hot flashes compared to placebo while reducing the risks to the endometrium. The most common adverse reactions (≥3 percent) were breast tenderness, headache, vaginal bleeding, vaginal discharge and pelvic pain. Additionally, there were no clinically significant changes in lipid, coagulation or glucose parameters as compared to placebo. There were no unexpected safety signals. The results of the trial were published in the journal Obstetrics & Gynecology.2 Important safety information, including the BOXED WARNING, for BIJUVA is provided below. The BIJUVA full prescribing information may be viewed by visiting www.BIJUVA.com.

“For the first time, we have a combination hormone therapy of bio-identical estradiol with bio-identical progesterone evaluated in a large, well-controlled, randomized clinical trial that has demonstrated both safety and efficacy for the treatment of moderate to severe hot flashes due to menopause,” said Dr. James Liu, M.D., President of the North American Menopause Society and Chairman of the Department of Obstetrics and Gynecology, UH Cleveland Medical Center. “The approval of BIJUVA represents an important, novel and effective treatment option for women and their healthcare providers to manage the vasomotor symptoms of menopause.”

“The approval of BIJUVA finally supports the science of combination bio-identical estradiol and progesterone,” said Kelly S. Selby, R.Ph., FIACP, pharmacist and compounding pharmacy owner. “Compounding pharmacists have been supporting women and their healthcare providers who request bio-identical hormone therapy for years and look forward to having BIJUVA as a commercially available option that is covered by insurance.”

TherapeuticsMD expects that BIJUVA will be available in the U.S. in the second quarter of 2019.