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The FDA has approved the first bioidentical hormone therapy combination of estradiol and progesterone for moderate to severe vasomotor symptoms associated with menopause, Therapeutics® reported in a press release.
The approval of the bioidentical estradiol and progesterone capsules (Bijuva), follows results from the phase 3 REPLENISH trial, first presented at the Endocrine Society annual meeting in April 2017 and reported by Endocrine Today, which demonstrated that a combination of 17beta-estradiol and progesterone appears to be safe and effective for men and women.
"The approval of Bijuva represents an important and new opportunity for menopausal women suffering from moderate to severe vasomotor symptoms," Brian Bernick, co-founder and director of Therapeutics®, said in the release. "Menopausal women and their health care providers have been seeking bioidentical combination therapies for many years without an FDA-approved option."
In the randomized, double-blind, placebo-controlled trial, the results of the study of estradiol / progesterone compared with placebo in 1,835 postmenopausal women aged 40 to 65 years with an intact urease and vasomotor symptoms: 1 mg / 100 mg (n = 415), 0.5 mg / 100 mg (n = 424), 0.5 mg / 50 mg (n = 421), 0.25 mg / 50 mg (n = 424), placebo (n = 151). The safety study is one of the most important recommendations for the treatment of endometrial biopsy at baseline and at day 326 with no major protocol violations.
No cases of endometrial hyperplasia or endometrial cancer were observed among any of the groups. Consensus reads of active and disordered hyperplasia at 12 months were identified in 2.9% of the 1 mg / 100 mg group, 1.7% of the 0.5 mg / 100 mg group, 0.3% of the 5 mg / 50 mg group, 1.1% of the 0.25 mg / 50 mg group, and none of the placebo group.
In the case of women, the average age was 54.6 years (mean BMI 26.6 kg / m2, 67% white). All women kept up to date at least 50 events per week.
Compared with the placebo group, women in the 1 mg / 100 mg and 0.5 mg / 100 mg groups reported statistically significant reductions in baselineP <0.05, for all) and 12 (P <.001, for all).
James Liu, MD, President of the North American Menopause Society and Chairman of the Department of Obstetrics and Gynecology at UH Cleveland Medical Center, said the FDA approval represents "an important, novel and effective treatment option for women and their health care providers."
"For the first time, we have a combination of bioidentical estradiol and bioidentical progesterone in a large, well-controlled, randomized clinical trial, which is highly selective in the treatment of moderate to severe menopause. "Liu said in the release.
The most common adverse reactions for Bijuva are breast tenderness (10.4%), headache (3.4%), vaginal bleeding (3.4%), vaginal discharge (3.4%) and pelvic pain (3.1%), according to the release.
Will be available in the United States beginning in the second quarter of 2019, according to Therapeutics®. – by Regina Schaffer
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