[ad_1]
Bijuva is the first bio-identical hormone therapy combining estradiol and progesterone in a single capsule
Bijuva is the first bio-identical hormone therapy combining estradiol and progesterone in a single capsule. Approval from the US Food and Drug Administration (FDA) was supported by the Phase 3 trial, which evaluated the safety and efficacy of oral contraceptives in general, postmenopausal women with severe symptoms. The co-primary efficacy endpoints were changed from place to place and followed by placebo.
Treatment with Bijuva led to a statistically significant reduction 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 Boxed Warnings concerning 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 combining bio-identical estradiol and progesterone," said Kelly S. Selby, RPh, FIACP, pharmacist and compounding pharmacy owner. "Medical insurance providers who request the same level of medical care and treatment"
Bijuva is expected to become available in the second quarter of 2019.
[ad_2]
Source link
