TherapeuticsMD, Inc., a women’s healthcare company, has received FDA approval for 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 bioidentical 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 four 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 results of the trial were published in the journal Obstetrics & Gynecology.2
“For the first time, we have a combination hormone therapy of bio-identical estradiol with bioidentical 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.
References 2003 FDA Draft Guidance for Industry Estrogen and Estrogen/Progestin Drug Products to Treat Vasomotor Symptoms and Vulvar and Vaginal Atrophy Symptoms – Recommendations for Clinical Evaluation https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugsgen/documents/document/ucm071643.pdf.  Lobo RA, Archer DF, Kagan R, Kaunitz AM, Constantine GD, Pickar JH, Graham S, Bernick B, Mirkin S. A 17β-Estradiol-Progesterone Oral Capsule for Vasomotor Symptoms in Postmenopausal Women: A Randomized Controlled Trial. Obstet Gynecol 2018;132:161-170.
(Source: TherapeuticsMD, Inc.)
Filed Under: Drug Discovery