The US Food and Drug Administration has granted approval to a new once-daily pill designed to alleviate moderate to severe hot flashes experienced by menopausal women. This innovative drug, named elinzanetant, developed by Bayer, is expected to be available for purchase in the United States starting this November under the brand name Lynkuet.
Elinzanetant operates by blocking the brain’s chemical signals responsible for the vasomotor symptoms associated with menopause, such as hot flashes and night sweats. It is estimated that over 80% of women encounter hot flashes during this transitional stage of life. “This FDA approval represents a bold step forward – 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, underlining the importance of offering more individualized menopause care.
While hormone therapy remains a common and effective option for many women experiencing these symptoms, it is not suitable for everyone, particularly those with certain health conditions or cancer histories. Experts suggest that non-hormonal alternatives are increasingly crucial for this demographic.
Results from a Phase 3 clinical trial that involved 628 postmenopausal women showed that, after 12 weeks, participants using elinzanetant reported a remarkable 73% reduction in the frequency of their vasomotor symptoms, compared to a 47% reduction in those receiving a placebo. The most reported side effects included drowsiness, fatigue, and headaches, highlighting the need for wise medical discretion in prescribing this treatment.
Dr. JoAnn Pinkerton, a researcher and director of midlife health at UVA Health, emphasized the significance of the study, stating that it confirmed not only rapid reduction in symptoms but also sustained relief over the year-long study period. “For those dealing with moderate to severe vasomotor symptoms due to menopause, treatment options have been limited, especially for those who cannot or choose not to undergo hormone therapy,” she noted.
Hot flashes, which can disrupt daily life both at work and home, are characterized by sudden feelings of intense heat, primarily affecting the upper body, and can trigger sweating and flushing. Claire Gill, president and founder of the National Menopause Foundation, further emphasized the importance of this new approval by stating, “It’s important that women know they have choices for treating moderate to severe hot flashes due to menopause.”
In recent months, the FDA has also approved fezolinetant, another non-hormonal alternative, that similarly addresses hot flashes by targeting a specific pathway in the brain. This evolving landscape of menopause treatments provides new hope for women seeking relief from debilitating symptoms, marking a positive advance in the management of menopause.