The US Food and Drug Administration (FDA) has approved a new once-a-day pill that treats moderate to severe hot flashes in menopausal women without using hormones, drugmaker Bayer announced Friday. The medication, elinzanetant, is expected to be available in the United States starting in November under the brand name Lynkuet.
Elinzanetant works by blocking the brain chemicals responsible for hot flashes and night sweats—commonly referred to by doctors as vasomotor symptoms (VMS)—in menopausal women. It is estimated that more than 80% of women experience hot flashes during menopause.
“This FDA approval represents a bold step forward – our first hormone-free treatment for alleviating vasomotor symptoms of menopause,” said Christine Roth, Bayer’s executive vice president of global product strategy and commercialization, in a news release. “There is a need for more individualized approaches to menopause care, and Lynkuet addresses a significant gap in treatment options.”
For many women, hormone therapy remains a safe and effective treatment for menopause symptoms like hot flashes. However, some women with underlying health conditions or a history of certain cancers are advised against hormone replacement therapies. For these women, alternative treatment options can be especially valuable.
A Phase 3 clinical trial involving 628 postmenopausal women found that those taking elinzanetant for 12 weeks experienced over a 73% reduction in the frequency of their vasomotor symptoms. In comparison, participants taking a placebo reported a 47% reduction.
The most common side effects reported by women taking the drug included drowsiness, fatigue, and headaches.
“This yearlong study not only confirmed the initial findings of rapid and significant reduction in the frequency and severity of hot flashes and night sweats but also provided evidence that these effects were sustained over a year, offering hope for longer-term relief,” said Dr. JoAnn Pinkerton, UVA Health’s director of midlife health and emeritus executive director of the North American Menopause Society, when the trial findings were published.
“For those dealing with moderate to severe VMS due to menopause, treatment options have been limited, especially for those who cannot or choose not to undergo hormone therapy,” Pinkerton added. “The disruptive nature of these bothersome hot flashes, particularly when severe, can significantly affect women’s daily lives both at work and at home, underscoring the urgent need for effective non-hormonal treatments.”
### Understanding Hot Flashes and Night Sweats
Hot flashes are sudden feelings of intense heat, typically concentrated around the face, chest, and head. They can cause intense sweating and flushing that may last several minutes. When hot flashes occur at night, they are known as night sweats. Women experiencing menopause may have these symptoms occasionally or multiple times a day, which can be highly disruptive.
“It’s important that women know they have choices for treating moderate to severe hot flashes due to menopause, and today’s approval further expands a woman’s options for managing these symptoms,” said Claire Gill, president and founder of the National Menopause Foundation, in Bayer’s announcement.
### A New Approach to Menopause Treatment
In 2023, the FDA approved another menopause drug called fezolinetant, which also serves as an alternative to traditional hormone replacement therapies for managing hot flashes. Both fezolinetant and elinzanetant are among the first drugs to target a recently discovered pathway in the brain linked to hot flashes.
As estrogen levels decline during menopause, nerves in the hypothalamus—a small, almond-sized region deep inside the brain responsible for regulating the body’s thermostat—become hyperactive and produce excess chemical signals known as neurokinins. These new drugs block the receptors where certain neurokinins attach, reducing their ability to stimulate the brain and cause hot flashes.
“Hot flashes, particularly when severe, can have an impact on women’s daily lives,” Pinkerton said in Bayer’s announcement. “This approval provides healthcare providers with a new treatment option that can be used as a first-line therapy for moderate to severe hot flashes due to menopause.”
https://www.phillytrib.com/news/health/new-menopause-drug-to-target-hot-flashes-without-hormones-gets-fda-approval/article_afb89015-b306-4634-b134-32b1ed48f6e8.html