(ANSA) – ROME, SEPTEMBER 19 – A non-hormonal oral therapy could help reduce moderate to severe vasomotor symptoms (VMS) associated with menopause, known as hot flashes. Approved by the Italian Medicines Agency (AIFA), Fezolinetant works by blocking neurokinins involved in the body’s thermoregulation, helping restore balance in the brain’s temperature control center (the hypothalamus) to reduce the number and intensity of hot flashes and night sweats. “This is a very sophisticated mechanism of action that acts right at the origin of the cause that causes the symptoms,” says Tommaso Simoncini, full professor of Gynecology and Obstetrics at the University of Pisa and President of the International Society of Gynecological Endocrinology (ISGE). “This is an important advantage as it allows clinicians to personalize therapy based on the type and severity of symptoms.” Globally, more than half of menopausal women experience VMS, with rates in Europe ranging from 56% to 97%, with a prevalence of moderate to severe cases in post-menopause of 40%. “In the past, it was believed that menopause and the associated vasomotor symptoms were the result of a decrease in estrogen alone; research in this field has revealed the role of specific neural pathways located in the hypothalamus, the area of the brain that regulates body temperature, in causing hot flashes,” explains Rossella Nappi, full professor of Obstetrics and Gynecology at the University of Pavia and President of the International Menopause Society (IMS). “Fezolinetant represents an additional therapeutic option for all women to treat a symptom without influencing the menopause phenomenon from a hormonal point of view, because it acts in a targeted way on neurokinins B, molecules that regulate body temperature at the brain level.” The drug’s approval is based on the results of three Phase 3 clinical trials that have enrolled a total of more than 3,000 individuals in Europe, the United States and Canada. (ANSA).
2024-09-19 22:42:27