Vasomotor symptoms occur when a woman reaches the state of menopause and the ovaries stop producing eggs, resulting in the reduction of secretion of hormones such as estrogen and progesterone. Therapies available for vasomotor symptoms of menopause are hormonal and non-hormonal, where hormone therapy is the most effective therapy for hot flashes. Several hormone therapies such as Duaveetm (conjugated estrogens/bazedoxifene), EvaMist and Minivelle (Estradiol Transdermal System) are already approved for the treatment of vasomotor symptoms of menopause. Non-hormonal therapies for vasomotor symptoms of menopause include Paroxetine, which has been used for many years in case of depression but can be taken at a lower dose for hot flushes.
Pipeline of vasomotor symptoms of menopause include ESN-364, NT 814 and MLE4901 that targets the Neurokinin 3 Receptor. Estrogen receptor is also an important target for several companies such as TherapeuticsMD, Radius Health, Inc., Mithra Pharmaceuticals etc. EndoCeutics, Inc and TherapeuticsMD, Inc are developing the fixed dose combination product, which are in phase III stage of development. EndoCeutics’s therapeutic candidate, (Acolbifene+Prasterone) a combination product, targets the estrogen receptor modulator (SERM), and has shown positive results in several clinical studies performed in healthy postmenopausal women and in women with advanced breast cancer.
TheapeuticsMD’s fixed dose novel combination product (Estradiol + Progesterone), which is also known as TX-001HR is being developed under 505(b) (2) regulatory pathway. The company is anticipating topline results in the fourth quarter of 2016 for the ongoing Replenish Trial. If the drug is approved, it would be the first and only FDA-approved bio-identical combination of estradiol and progesterone for treatment of moderate-to-severe vasomotor symptoms due to menopause.
