FDA Approves Hormone-Free Medication for Menopausal Hot Flashes
The US Food and Drug Administration has granted approval for a new once-daily medication that provides hormone-free relief for moderate to severe hot flashes in menopausal women, pharmaceutical company Bayer announced Friday.
The medication, elinzanetant, will become available in the United States starting November under the brand name Lynkuet, according to Bayer’s statement.
The drug functions by blocking specific brain chemicals responsible for hot flashes and night sweats—medically termed vasomotor symptoms—in menopausal women. Research indicates that over 80% of women experience hot flashes during menopause.
Expanding Treatment Options
“This FDA approval marks a significant advancement—our first hormone-free treatment for alleviating vasomotor symptoms of menopause,” stated Christine Roth, Bayer’s executive vice president of global product strategy and commercialization, in Friday’s news release.
“There’s a need for more personalized approaches to menopause care, and Lynkuet addresses a substantial gap in treatment alternatives,” she added.
While hormone therapy can provide safe and effective relief for menopause symptoms like hot flashes for many women, certain individuals with specific health conditions or medical histories, including particular cancer diagnoses, are often advised against hormone replacement therapies. Healthcare experts emphasize that alternative treatment options prove valuable for these patients.
Clinical Trial Results Demonstrate Efficacy
A Phase 3 clinical investigation of elinzanetant involving 628 postmenopausal women revealed that participants taking the medication for 12 weeks experienced more than a 73% reduction in vasomotor symptom frequency. Comparatively, those receiving a placebo reported a 47% reduction.
The most frequently reported side effects among women taking the medication included drowsiness, fatigue, and headaches.
“This yearlong study not only validated the initial findings of rapid and substantial reduction in hot flash and night sweat frequency and severity but also demonstrated that these effects persisted over a year, providing hope for extended relief,” explained researcher Dr. JoAnn Pinkerton, UVA Health’s director of midlife health and emeritus executive director of the North American Menopause Society, in a statement last month when trial results were published.
“For those experiencing moderate to severe VMS due to menopause, treatment options have been constrained, especially for those who cannot or prefer not to undergo hormone therapy,” Pinkerton noted. “The disruptive nature of these troublesome hot flashes, particularly when severe, can substantially affect women’s daily lives, both professionally and personally, highlighting the critical need for effective non-hormonal treatments.”
Understanding Hot Flashes
Hot flashes manifest as sudden sensations of intense heat typically concentrated around the face, chest, and head. They can trigger severe sweating and flushing that may persist for several minutes. When occurring at night, these episodes are termed night sweats. Menopausal women may experience them sporadically or multiple times daily, which can prove extremely disruptive.
“It’s essential that women understand 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 Friday announcement.
Scientific Breakthrough in Hot Flash Treatment
In 2023, the FDA approved the menopause medication fezolinetant, which also serves as an alternative to traditional hormone replacement therapies for managing hot flashes. Fezolinetant and elinzanetant are among the first medications to utilize a newly understood pathway in the brain that appears to regulate hot flashes.
As estrogen levels decline during menopause, nerves in the hypothalamus—a small region deep within the brain that helps regulate body temperature—become hyperactive and generate excessive chemical signals called neurokinins. Both new medications block the cellular receptors where certain neurokinins attach, reducing their capacity to stimulate the brain to trigger hot flashes.
“Hot flashes, particularly when severe, can significantly impact women’s daily lives,” Pinkerton said in Bayer’s announcement. “This approval provides healthcare providers with a new treatment option that can be utilized as a first-line therapy for moderate to severe hot flashes due to menopause.”
The availability of hormone-free alternatives represents a meaningful advancement for women seeking menopause symptom relief while avoiding hormone-based therapies due to medical considerations or personal preference.
