Bayer’s Non-Hormonal Hot Flash Treatment Receives FDA Clearance
The US Food and Drug Administration has authorized a new daily medication that offers hormone-free treatment for moderate to severe hot flashes in menopausal women, pharmaceutical manufacturer Bayer disclosed Friday.
The medication, elinzanetant, is scheduled to launch in the United States in November under the commercial name Lynkuet, Bayer confirmed.
This drug operates by inhibiting specific brain chemicals that cause hot flashes and night sweats—clinically known as vasomotor symptoms—in menopausal women. Studies show that more than 80% of women encounter hot flashes during menopause.
Addressing an Unmet Medical Need
“This FDA authorization represents a significant milestone—our first hormone-free therapy for reducing vasomotor symptoms of menopause,” declared Christine Roth, Bayer’s executive vice president of global product strategy and commercialization, in Friday’s press release.
“There’s a requirement for more customized approaches to menopause management, and Lynkuet fills a considerable void in available treatments,” she continued.
For numerous women, hormone therapy can deliver safe and effective relief for menopause symptoms including hot flashes. However, some individuals with particular health conditions or medical backgrounds, including certain malignancies, are frequently counseled against hormone replacement therapies. Medical professionals note that alternative treatment options can be beneficial for these patients.
Clinical Evidence Supports Approval
A Phase 3 clinical trial of elinzanetant encompassing 628 postmenopausal women demonstrated that participants using the medication for 12 weeks reported more than a 73% decrease in vasomotor symptom frequency. In comparison, those receiving a placebo experienced a 47% decrease.
The most commonly observed side effects in women using the medication were drowsiness, fatigue, and headaches.
“This year-long investigation not only confirmed the preliminary findings of swift and significant reduction in hot flash and night sweat frequency and intensity but also provided evidence that these effects endured over a year, offering promise for sustained relief,” stated 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 following trial results publication.
“For individuals dealing with moderate to severe VMS from menopause, treatment alternatives have been limited, especially for those who cannot or choose not to pursue hormone therapy,” Pinkerton observed. “The disruptive character of these bothersome hot flashes, particularly when more intense, can profoundly affect women’s daily routines, both at work and home, emphasizing the pressing need for effective non-hormonal treatments.”
The Impact of Hot Flashes
Hot flashes present as sudden sensations of extreme heat usually focused around the face, chest, and head. They can also cause intense sweating and flushing that may continue for several minutes. When these episodes occur during nighttime, they’re called night sweats. Women experiencing menopause may have them infrequently or numerous times per day, which can be highly disruptive.
“It’s crucial that women recognize they have options for addressing moderate to severe hot flashes from menopause, and today’s approval further broadens a woman’s choices for managing these symptoms,” remarked Claire Gill, president and founder of the National Menopause Foundation, in Bayer’s Friday statement.
Revolutionary Brain Pathway Discovery
In 2023, the FDA authorized the menopause drug fezolinetant, which also functions as an alternative to conventional hormone replacement therapies for controlling hot flashes. Fezolinetant and elinzanetant rank among the first medications to leverage a recently discovered pathway in the brain that seems to control hot flashes.
As estrogen diminishes during menopause, nerves in the hypothalamus—a small region deep in the brain whose responsibilities include helping regulate body temperature—become overactive and produce excessive chemical signals termed neurokinins. Both new medications block the cellular doorways where specific neurokinins attach, diminishing their ability to activate the brain to cause hot flashes.
“Hot flashes, especially when severe, can significantly influence women’s daily experiences,” Pinkerton noted in Bayer’s announcement. “This approval equips healthcare providers with a new treatment alternative that can be employed as a primary therapy for moderate to severe hot flashes from menopause.”
The introduction of hormone-free options marks an important development for women seeking menopause symptom management while avoiding hormone-based treatments due to medical factors or personal choice. With multiple non-hormonal alternatives now available, healthcare providers can offer more tailored approaches to menopause care, ensuring that more women have access to effective relief from debilitating symptoms.
