[Reading Science] Red, Hot, and Pitiful 'Eomma Face'... First Treatment Developed

US FDA Approves Treatment for Menopausal Women's Facial Hot Flashes
First Non-Hormonal Therapy, Reduces Symptoms by 60%

The first-ever non-hormonal treatment for hot flushes, a common symptom experienced by menopausal women in the United States, has been officially approved. Despite clinical trials being conducted during the COVID-19 pandemic, there was an overwhelming number of applicants, highlighting the high expectations among women.

Photo by Getty Images Bank

On the 12th, the U.S. Food and Drug Administration (FDA) approved fezolinetant (brand name Veozah), a treatment for hot flushes developed by Astellas Pharma based in Tokyo, Japan, according to a report by the international scientific journal Nature on the 15th (local time). Menopausal women experience various symptoms such as headaches, hot flushes, depression, loss of concentration, and anxiety, alongside a decrease in female hormones and cessation of menstruation. Hot flushes are the most common symptom, affecting over 80% of women. In severe cases, it feels as if heat is radiating throughout the upper body. Women suffer from facial flushing and heat sensations accompanied by sweating. Some experience dizziness and palpitations. During the day, these symptoms can interfere with work, exercise, sexual and social relationships, and at night, they can disrupt sleep. Prolonged symptoms can have a significant negative impact on women's health. Studies in the U.S. have also shown that Black women experience hot flushes more frequently and intensely than White women. Until now, hormone replacement therapies that slow the reduction of estrogen or other female hormones have been used, but these treatments are not suitable for patients with breast cancer, stroke, or migraines.

The development of this treatment began in the 1990s when a research team at the University of Arizona discovered that certain brain cells in menopausal women were more than twice as swollen compared to premenopausal women. The team named these cells KNDy neurons and found through animal experiments that blocking the receptors that interact with a substance called neurokinin B prevented hot flushes. Subsequent clinical studies confirmed that the same mechanism occurs in the human brain. Based on this, fezolinetant was developed as a drug that blocks the neurokinin-3 receptor protein, which responds to neurokinin B and mediates heat production in the body. Clinical results showed that administering the drug to women experiencing moderate to severe hot flushes weekly significantly reduced the frequency of symptoms by about 60%. This was a clear improvement compared to the 45% reduction seen in the placebo group. Additionally, women treated with fezolinetant experienced a reduction in symptom severity and improved sleep quality. However, the drug did not completely eliminate the symptoms.

Additional research on the thermoregulation mechanism confirmed in this study is underway. Stephanie Correa, a professor of neuroendocrinology at the University of California, stated, "Body temperature is regulated by a complex network of brain circuits, and fezolinetant targets one of these connections." She added, "Animal experiments are ongoing to discover additional treatments." However, she noted, "Most previous research on brain circuit connections related to thermoregulation has been conducted primarily on males, so many challenges remain. There are many unresolved issues regarding how to apply findings from animal studies to humans, especially women."

In any case, the emergence of this first-ever non-hormonal treatment for menopausal syndrome has generated very high expectations among women. Although clinical trials were conducted during the height of the COVID-19 pandemic, when it was expected that recruiting participants would be difficult, many people applied, alleviating concerns. This indicates a high potential demand for this treatment. Marcy English, Vice President of the Biopharmaceutical Division at Astellas Pharma, said, "Since most people were reluctant to go out and avoided visiting medical facilities during that period, we expected difficulties in recruiting participants as with other studies. However, we were very surprised to hear from clinical trial researchers that 'all women wanted to participate in this study.'" Meanwhile, the number of women worldwide experiencing menopausal syndrome is expected to exceed one billion within a few years.