FDA approves Bijuva to treat moderate to severe vasomotor symptoms due to menopause. Therapeutics MD

Therapeutics MD, Inc. announced that the FDA has approved 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 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 4 and 12 as compared to placebo. 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 most common adverse reactions (?3 percent) were breast tenderness, headache, vaginal bleeding, vaginal discharge and pelvic pain. Additionally, there were no clinically significant changes in lipid, coagulation or glucose parameters as compared to placebo. There were no unexpected safety signals. The results of the trial were published in the journal Obstetrics & Gynecology.

See-"REPLENISH Trial: Combination Capsule of Estradiol/Progesterone (TX-001HR) for Treating Hot Flushes"-]Archer, David F., MD; Graham, Shelli, PhD; Gasper, Gina; Constantine, Ginger, MD; et al., Obstetrics & Gynecology: May 2017 - Volume 129 - Issue 5 - p S133�S134 doi: 10.1097/01.AOG.0000514678.75674.b8 Monday, May 8, 2017: