TherapeuticsMD, Inc. (NASDAQ: TXMD) sat in the driveway Monday, after the company reported the FDA approval of TX-001HR: BIJUVA capsules for the treatment of moderate to severe vasomotor symptoms due to menopause.
The company, based in Boca Raton, Florida, announced 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 of BIJUVA represents an important and new opportunity for menopausal women suffering from moderate to severe vasomotor symptoms. Menopausal women and their healthcare providers have been seeking bio-identical combination therapies for many years without an FDA-approved option," said Dr. Brian Bernick, Co-Founder and Director of TherapeuticsMD.
"BIJUVA is the first and only FDA-approved combination of bio-identical hormones, offering a proven balance of bio-identical estradiol to reduce moderate to severe hot flashes combined with bio-identical progesterone to reduce the risks to the endometrium."
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 four and 12 as compared to placebo.
Shares were pretty much unchanged at $5.09
