Bijuva (estradiol and progesterone) capsules have received FDA approval for the treatment of vasomotor symptoms due to menopause in women with a uterus, announced pharmaceutical company TherapeuticsMD. Vasomotor symptoms are characterized by night sweats, hot flashes, and flushes.
The drug is the first bio-identical hormone therapy combining estradiol and progesterone in a single capsule. Approval from the Food and Drug Administration (FDA) was supported by the Phase 3 Replenish trial. The trial evaluated the efficacy and safety of Bijuva in generally healthy, postmenopausal women with a uterus for the treatment of moderate to severe hot flashes.
Bijuva is the first bio-identical hormone therapy combining estradiol and progesterone in a single capsule. Approval from the Food and Drug Administration (FDA) was supported by the Phase 3 Replenish trial which evaluated the safety and efficacy of Bijuva in generally healthy, postmenopausal women with a uterus for the treatment of moderate to severe hot flashes.
Key Findings of the Trial:
- The co-primary efficacy endpoints were changed from baseline in the number and severity of hot flashes at weeks 4 and 12 vs placebo.
- Treatment with Bijuva led to a statistically significant reduction from baseline in both the frequency and severity of hot flashes vs placebo while reducing risks to the endometrium (primary safety endpoint).
- Breast tenderness, headache, vaginal bleeding, vaginal discharge, and pelvic pain were the most common adverse reactions reported.
As with other hormone replacement therapies, Bijuva carries several Boxed Warnings regarding the risks of cardiovascular disorders, breast cancer, endometrial cancer, and probable dementia. There is no evidence that bio-identical hormones are safer or more effective than synthetic hormones.
Bijuva will be available as 1mg estradiol/100mg progesterone strength capsules in 30-count blister packs. “The approval of Bijuvia finally supports the science of combination bio-identical estradiol and progesterone,” said Kelly S. Selby, RPh, FIACP, pharmacist, and compounding pharmacy owner. “Compounding pharmacists have been supporting women and their health care 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.”
Bijuva is expected to become available in the second quarter of 2019.
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