The US Food and Drug Administration has given the green light to a new once-daily pill that works without hormones to ease moderate to severe hot flashes in menopausal women, Bayer announced Friday. The drug, called elinzanetant, will be available in the US starting in November under the brand name Lynkuet, according to Bayer. It works by targeting brain chemicals responsible for hot flashes and night sweats, medically referred to as vasomotor symptoms. Experts estimate that over 80% of women experience hot flashes during menopause.“This FDA approval marks a bold leap forward, our first non-hormonal treatment for vasomotor symptoms of menopause,” said Christine Roth, Bayer’s executive vice president of global product strategy and commercialization, in a news release Friday. “There’s a growing need for personalized approaches to menopause care, and Lynkuet fills a crucial gap in treatment options.”For many women, hormone therapy can be a safe and effective way to manage symptoms like hot flashes. However, some women with certain health conditions or a history of diseases, including specific cancers, are sometimes advised against hormone replacement therapy. In such cases, alternative options like Lynkuet may be particularly valuable.Clinical Trial Shows Promising ResultsA Phase 3 clinical trial involving 628 postmenopausal women found that those taking elinzanetant for 12 weeks saw more than a 73% reduction in the frequency of their vasomotor symptoms, compared with a 47% reduction in those who received a placebo. The most commonly reported side effects were drowsiness, fatigue, and headaches.“This year-long study not only confirmed rapid and substantial relief from the frequency and severity of hot flashes and night sweats but also showed that these benefits lasted for a full year, offering hope for long-term symptom control,” said Dr. JoAnn Pinkerton, director of midlife health at UVA Health and emeritus executive director of the North American Menopause Society, when the trial results were published.“For women facing moderate to severe vasomotor symptoms during menopause, treatment options have been limited, especially for those who cannot or prefer not to use hormone therapy,” Pinkerton added. “Severe hot flashes can disrupt daily life, work, and home routines, highlighting the need for effective non-hormonal treatments.”Hot Flashes and Night SweatsHot flashes are sudden, intense feelings of heat that usually affect the face, chest, and head. They can bring on heavy sweating and flushing for several minutes. Nighttime episodes are called night sweats. Women can experience hot flashes sporadically or multiple times a day, making them highly disruptive.“It’s important that women know there are choices to treat moderate to severe hot flashes, and this approval gives healthcare providers another option,” said Claire Gill, president and founder of the National Menopause Foundation, in Bayer’s announcement.A New Era of Menopause TreatmentIn 2023, the FDA approved another non-hormonal menopause drug, fezolinetant, which also provides an alternative to traditional hormone therapies for hot flashes. Fezolinetant and elinzanetant are among the first drugs to target a recently discovered brain pathway involved in regulating hot flashes.During menopause, declining estrogen levels trigger overactive nerves in the hypothalamus, a small region deep in the brain that helps control the body’s thermostat. These nerves release too many chemical signals called neurokinins. Both drugs block neurokinin receptors on brain cells, reducing the signals that trigger hot flashes.“Severe hot flashes can significantly affect daily life,” Pinkerton said. “This approval gives healthcare providers a new, first-line option to help women with moderate to severe menopause-related hot flashes.”
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