Vasomotor Symptoms of Menopause Therapeutics Pipeline Analysis, 2016

Vasomotor symptoms occur when a woman reach the state of menopause and ovaries stop producing eggs, and there is a reduction in secretion of hormones such as estrogen and progesterone. It usually occurs naturally, most often between age of 45 years to 51 years. The women feel perimenopausal transition that generally occurs prior to cessation of menstruation. During perimenopausal transition, the menstruation cycle becomes erratic, leading to irregular menses, heavy bleeding, hot flashes and dryness of vagina. Decline in circulating estrogen level represents clinical symptoms of menopause that occurs after cessation of ovarian follicular function. The most common symptom of vasomotor menopause is hot flashes and hormone therapy is the most effective therapy for hot flashes. From many years, hot flashes have been treated with either oral or transdermal forms of estrogen alone or in combination with progesterone.

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The vasomotor symptoms of menopause therapeutics have more than 20 drugs. In pipeline analysis, drugs are analyzed on the basis of route of administration and molecule type. The pipeline is also analyzed on the basis of monotherapy and combination therapy, and different clinical phases including Phase III, Phase II, Phase I and Pre-Clinical stage.

Phase III

Phase III clinical trial known for the comparison of new treatments with the standard treatment in which safety, efficacy and side effects of new intervention is compared with the already existing treatment. The Phase III clinical trial takes around 2-3 years to complete and the total number of participants vary from 100-1,000. In vasomotor symptoms of menopause, there are 2 drugs in Phase III clinical trial. For instance, (Estradiol + Progesterone) is under development by TherapeuticsMD, Inc. The drug candidate is a fixed dose novel combination of 17ß-estradiol and progesterone, which is developed for the treatment of moderate to severe vasomotor symptoms due to menopause, including hot flashes, night sweats, sleep disturbances, vaginal dryness, and for post-menopausal women with an intact uterus.

Phase II

ESN-364, is a phase II drug candidate of Ogeda SA being developed for the treatment of vasomotor symptoms of menopause, polycystic ovary syndrome and uterine fibroids. In vasomotor symptoms of menopause, there are 8 drugs in Phase II clinical trial. Phase II clinical trial is the second phase that answer safety, efficacy and dosing of the new intervention. It takes around 2 years to complete and between 100 – 120 patients participate in the Phase II trial.

Phase I

FP-101 is under development by Fervent Pharmaceuticals for vasomotor symptoms. FP-101 is an oral formulation of a non-hormonal/non-herbal compound for the treatment of vasomotor symptoms associated with menopause and hot flashes. In vasomotor symptoms of menopause, there are 4 drugs in Phase I clinical trial. In Phase I clinical trial, safety of the new intervention is determined. The trial takes around 1-2 years to complete and the total number of volunteers participating in the trial vary between 15 – 30.

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Pre-Clinical

HBN-2, a preclinical drug candidate of Hibernaid Inc., is being developed to minimize menopausal related hot-flashes or vasomotor symptoms of menopause, progeria and mild concussion. Preclinical study is also known as animal study. It is done before testing a drug in people to find out the toxicity profile of the drug. Preclinical study is of two types, including In vitro and In vivo.

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Pipeline analysis provides description about the key companies developing vasomotor symptoms of menopause drugs. Some of the key players actively involved in the research and development are TherapeuticsMD, Inc., Ogeda SA, NeRRe Therapeutics Ltd., Radius Health, Inc. and Pherin Pharmaceuticals, Inc.

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