The US Food and Drug Administration has approved another once-a-day pill that works without hormones to treat moderate to severe hot flashes in menopausal women, drugmaker Bayer said Friday.
The drug, elinzanetant, is expected to be available in the United States beginning in November under the brand name Lynkuet, Bayer said.
It works by blocking the brain chemicals responsible for hot flashes and night sweats – what doctors call vasomotor symptoms – in menopausal women. It’s estimated that more than 80% of women have hot flashes during menopause.
“This FDA approval represents a bold step forward – our first hormone-free treatment for alleviating vasomotor symptoms of menopause,” Christine Roth, Bayer’s executive vice president of global product strategy and commercialization, said in a news release Friday.
“There is a need for more individualized approaches to menopause care, and Lynkuet addresses a significant gap in treatment options,” she said.
For many women, hormone therapy can be a safe and effective treatment for menopause symptoms such as hot flashes. But some with underlying health conditions or histories, including certain cancers, are sometimes advised against using hormone replacement therapies. Experts say that for those women, alternative treatment options can be helpful.
A Phase 3 clinical trial of elinzanetant that included 628 postmenopausal women found that those taking the drug for 12 weeks reported a more than 73% reduction in the frequency of their vasomotor symptoms, or VMS. In contrast, those taking a placebo reported a 47% reduction.
The most common side effects in women taking the drug were 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,” researcher Dr. JoAnn Pinkerton, UVA Health’s director of midlife health and emeritus executive director of the North American Menopause Society, said in a statement last month when the trial findings were published.
“For those dealing with moderate to severe VMS due to menopause, the treatment options have been limited, especially for those who cannot or choose not to undergo hormone therapy,” Pinkerton said. “The disruptive nature of these bothersome hot flashes, particularly when they are more severe, can significantly affect women’s daily lives, both at work and at home, underscoring the urgent need for effective non-hormonal treatments.”
Hot flashes are a sudden feeling of being very hot that’s usually centered around the face, chest and head. They can also cause intense sweating and flushing that may last several minutes. When this happens at night, it’s called a night sweat. Women in menopause may get them occasionally or many times a day, which can be extremely 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 treating these symptoms,” Claire Gill, president and founder of the National Menopause Foundation, said in Bayer’s announcement Friday.
In 2023, the FDA approved the menopause drug fezolinetant, which also works as an alternative to traditional hormone replacement therapies for managing hot flashes. Fezolinetant and elinzanetant are among the first drugs to take advantage of a newly understood pathway in the brain that appears to control hot flashes.
As estrogen decreases during menopause, nerves in the hypothalamus — an almond-size region deep inside the brain whose functions include helping regulate the body’s thermostat — become hyperactive and produce an overabundance of chemical signals called neurokinins. Both of the new drugs block the doorways on cells where certain neurokinins dock, which turns down their ability to stimulate the brain to 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 first-line for moderate to severe hot flashes due to menopause.”
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