FDA News

FDA approves bioidentical hormone therapy for menopausal hot flashes

The FDA has approved the first bioidentical hormone therapy combination of estradiol and progesterone for moderate to severe vasomotor symptoms associated with menopause, TherapeuticsMD announced 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 reducing hot flash frequency and severity in menopausal women with a uterus.

“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 TherapeuticsMD, 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 REPLENISH trial, researchers evaluated the safety and efficacy of four doses of estradiol/progesterone against placebo in 1,835 postmenopausal women aged 40 to 65 years with an intact uterus 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 evaluated women who received at least one treatment dose with an acceptable 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 an effectiveness substudy, researchers evaluated self-reported hot flash frequency and severity in 599 of the women (mean age 54.6 years; mean BMI 26.6 kg/m2; 67% white). All women kept hot flash diaries leading up to baseline and reported at least 7 events per day or 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 from baseline in hot flash frequency and severity at weeks 4 (P < 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 hormone therapy of bioidentical 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,” 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.

Bijuva will likely be available in the United States beginning in the second quarter of 2019, according to TherapeuticsMD. – by Regina Schaffer

The FDA has approved the first bioidentical hormone therapy combination of estradiol and progesterone for moderate to severe vasomotor symptoms associated with menopause, TherapeuticsMD announced 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 reducing hot flash frequency and severity in menopausal women with a uterus.

“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 TherapeuticsMD, 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 REPLENISH trial, researchers evaluated the safety and efficacy of four doses of estradiol/progesterone against placebo in 1,835 postmenopausal women aged 40 to 65 years with an intact uterus 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 evaluated women who received at least one treatment dose with an acceptable 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 an effectiveness substudy, researchers evaluated self-reported hot flash frequency and severity in 599 of the women (mean age 54.6 years; mean BMI 26.6 kg/m2; 67% white). All women kept hot flash diaries leading up to baseline and reported at least 7 events per day or 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 from baseline in hot flash frequency and severity at weeks 4 (P < 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.”

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“For the first time, we have a combination hormone therapy of bioidentical 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,” 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.

Bijuva will likely be available in the United States beginning in the second quarter of 2019, according to TherapeuticsMD. – by Regina Schaffer