A new treatment for menopause has just been approved by the U.S. Food and Drug Administration (FDA), bringing hope to millions of women who struggle with uncomfortable symptoms such as hot flashes and night sweats.
The drug, called elinzanetant, was tested successfully at several hospitals, including UVA Health, and has been shown to reduce the frequency and severity of hot flashes while improving sleep and overall quality of life.
Menopause is a natural stage in every woman’s life, typically occurring between ages 45 and 55, when the ovaries stop producing estrogen and progesterone.
These hormonal changes can cause a range of symptoms such as mood swings, trouble sleeping, night sweats, and the sudden sensation of heat known as hot flashes. While these symptoms are temporary for some, many women experience them for years, making daily life and sleep difficult.
Hormone replacement therapy (HRT) has long been the main treatment for menopausal symptoms. It works by replacing the hormones that the body stops producing. However, not all women can take HRT because of its potential side effects.
Some women experience mild reactions like bloating, headaches, or breast tenderness, while others face more serious risks such as blood clots, strokes, or certain cancers when taking estrogen-based treatments. For women who have had blood clots or hormone-sensitive cancers, hormone therapy is not a safe option.
Elinzanetant is different because it does not contain any hormones. Instead, it works on the brain receptors that are involved in regulating body temperature and mood. By targeting these receptors, the drug helps to reduce the hot flashes and improve sleep, without the risks that come with hormone therapy.
Dr. JoAnn Pinkerton, the director of midlife health at UVA Health and a leading researcher on the project, explained that more than one-third of women experience serious menopausal symptoms that can last for over a decade.
“Many women continue to suffer without treatment or support,” she said. “With the approval of elinzanetant, women now have a safe and effective option that can improve their quality of life.”
The Oasis trials, conducted in the United States, Europe, and Israel, tested the safety and effectiveness of the new drug. Researchers enrolled postmenopausal women between the ages of 40 and 65 who were experiencing moderate to severe hot flashes.
Participants were randomly assigned to take either a daily 120 mg dose of elinzanetant or a placebo. The study lasted for 26 weeks, with the first 12 weeks comparing elinzanetant to a placebo and the next 14 weeks allowing all participants to take the drug.
The results were impressive. Within the first week, women taking elinzanetant noticed a clear improvement in their symptoms. By week 12, their hot flashes were less frequent and less intense, and their sleep and mood had also improved.
Women who took the placebo initially experienced similar benefits once they switched to elinzanetant. The most common side effects were mild headaches and fatigue, and no severe adverse effects were reported.
These positive results convinced the FDA to approve elinzanetant, marking an important milestone in women’s health. For many women who cannot or do not want to use hormone therapy, this drug provides a long-awaited alternative.
In reviewing and analyzing the findings, the research shows that elinzanetant fills a significant gap in menopause treatment. Its non-hormonal nature makes it suitable for a wider range of women, especially those with health conditions that prevent them from using traditional hormone therapy.
The trials demonstrated consistent improvements in symptoms and quality of life without serious risks. While further long-term studies may help confirm its safety over the years, elinzanetant already represents a major advancement in how menopause can be managed safely and effectively.
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