The U.S. Food and Drug Administration has approved elinzanetant to treat hot flashes and night sweats. Photo by Maansi Srivastava for The Washington Post/Getty Images/File.
As reported by CNN
FDA has approved another daily non-hormonal pill to relieve moderate to severe hot flashes in women during menopause, Bayer said on Friday.
The drug, called elinzanetant, is expected to launch in the United States in November under the Lynkuet brand, Bayer said.
The medication works by blocking chemical signals in the brain that are responsible for hot flashes and night sweats – vasomotor symptoms of menopause. It is estimated that more than 80% of women experience hot flashes during menopause.
“This FDA approval reflects a bold step forward – our first non-hormonal means to relieve vasomotor symptoms of menopause.”
“There is a need for more individualized approaches to menopause care, and Lynkuet fills a significant gap in treatment options,” said Kristin Roth, Bayer’s Executive Vice President of Global Product Strategy and Commercialization.
For many women, hormone therapy can be safe and effective for menopausal symptoms such as hot flashes. But for some – due to existing chronic conditions or history, including certain types of cancer – its use is advised to be avoided. Experts emphasize that for such patients, alternative treatment options may be beneficial.
Trial results and side effects
In a phase 3 study of elinzanetant, which enrolled 628 postmenopausal women, participants who took the drug for 12 weeks reported a reduction in the frequency of vasomotor symptoms by more than 73%, while the group receiving placebo saw a 47% reduction.
The most common adverse effects among women taking the drug were drowsiness, fatigue, and headache.
“This year’s one-year study not only confirmed the initial findings of rapid and substantial reductions in the frequency and severity of hot flashes and night sweats, but also showed that these effects lasted for a year, offering hope for long-term relief.”
“For those experiencing moderate to severe vasomotor symptoms due to menopause, treatment options were limited, especially for those who cannot or choose not to undergo hormone therapy. The bothersome nature of these persistent hot flashes, particularly when they are more intense, can significantly affect women’s daily lives, both at work and at home, underscoring the urgent need for effective non-hormonal treatment options.”
What hot flashes are and their impact on life
Hot flashes are a sudden feeling of intense warmth, usually concentrated in the face, chest, and head. They can be accompanied by intense sweating and flushing, lasting several minutes. If this happens at night – it is night sweats. Women during menopause may experience them occasionally or several times a day, which can significantly affect daily life.
“It is important that women know they have a choice of treatments for moderate to severe hot flashes due to menopause, and today’s approval expands the treatment options for these symptoms,” said Claire Gill, president and founder of the National Menopause Foundation, in a Bayer statement.
“It is important that women know they have a choice of treatments for moderate to severe hot flashes due to menopause, and today’s approval expands the treatment options for these symptoms.”
In 2023, the FDA also approved fezolinetant, which serves as an alternative to traditional hormone therapies for controlling hot flashes. Fezolinetant and elinzanetant are among the first drugs to use a new pathway in the brain that is believed to regulate hot flashes.
Estrogen changes during menopause lead to increased nerve activity in the hypothalamus – the part of the brain that regulates thermoregulation. Both new drugs block the “doors” on cells where certain neurokinins accumulate, reducing their ability to stimulate the brain to produce hot flashes.
“Hot flashes, especially when they are severe, can impact women’s daily lives.”
This material was also developed with input from specialists at the media-information group covering relevant topics, which broadened the data’s reach and context.
The new non-hormonal approach to treating vasomotor symptoms opens up new opportunities for women seeking alternatives to hormone therapy or who are unable to use it due to personal or medical circumstances. With every step, scientific data support safe and effective treatment options that can significantly improve daily life during menopause.
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