A new era in menopause treatment appears to be at hand. This week, drugmaker Bayer published the results of two successful Phase III trials testing its investigational drug elinzanetant as a treatment for hot flashes. The drug is now poised to become the first non-hormonal drug of its kind to be approved in the world.
Hot flashes and night sweats are common symptoms of menopause, affecting about 80% of women in their lifetime. Formally known as vasomotor symptoms, hot flushes are characterized by sudden bursts of warmth, redness, and sweating, usually around the face, neck, and chest (night sweats are similar, but occur at night and while you sleep). These episodes can be very uncomfortable, and more severe cases are thought to raise the risk of insomnia and depression. Although hot flashes subside over time, they usually last at least two years, and some women will experience them for ten years or more, according to the Mayo Clinic.
Historically, hot flashes have been successfully treated with hormone therapy, which aims to replace the estrogen and progesterone levels that drop with menopause. Beginning in the late 1990s, however, large-scale trials began to show that hormone therapy could raise the risk of other health problems, including heart disease, breast cancer, and stroke, in menopausal women—results that quickly led to large and dangerous skin. continued decline in treatment. Recent research and recent data analysis have found that these risks may be overestimated and can be safely reduced. Organizations such as the North American Menopause Society currently say that the benefits of hormone replacement therapy outweigh any potential harm for most women who start treatment before age 60 and/or within ten years of their last period. But hormone therapy remains more popular than ever, and there are some women who are at greater risk of complications from it, such as those with a history of breast cancer.
Women who are unwilling or unable to use hormones in their hot flashes have had limited other options until now, such as low doses of certain SSRIs. But in the early 2010s, scientists finally began to uncover some of the mechanisms behind the warming. They found that a group of neurons that produce kisspeptin, neurokinin B (NKB), and dynorphin (known as KNDy neurons) were important in causing the changes associated with low estrogen levels. Recent studies have found that blocking the activity of certain receptors in these cells can safely reduce heat exposure. And in May 2023, the Food and Drug Administration approved Astellas Pharma’s fezolinetant, the first drug that treats hot flashes by blocking one of these receptors, NK3.
Bayer’s elizanetant blocks both NK3 and NK1 receptors, a two-step design that scientists hope will not only reduce hot flashes but also the sleep problems often associated with menopause. In a large Phase III trial of the drug, published Thursday in the journal STOPthose hopes seem to have been confirmed.
The study involved more than 700 women in their 40s and 50s diagnosed with moderate to severe hot flashes, who were randomized to receive elinzanetant or a placebo. In both trials, researchers found that women taking elinzanetant (a once-daily pill) experienced a significant reduction in hot flashes relative to controls. At the end of the study, 26 weeks later, more than 80 percent of women in the chair saw a greater than 50% reduction in symptoms, including women who switched to the drug 12 weeks into their trial. Participants also reported fewer sleep disturbances than women taking a placebo, and reported a higher increase in their menopause-related quality of life. Elinzanetant has also been shown to be safe, with the most common adverse events (compared to placebo) in those taking the drug being headaches and fatigue.
“Elinzanetant has the potential to provide a well-tolerated and effective non-hormonal treatment option to address the unmet health needs of many people with moderate to severe menopause. [hot flashes],” researchers at STOP paper he wrote.
The results follow similarly promising findings from the company’s other Phase III study of elinzanetant, which was announced earlier this March. And the company now plans to send data from all three studies to regulators to get approval for the drug as a treatment for moderate to severe heat—an approval that should be in the bag, barring any major surprises.
However, although the arrival of these drugs is very important, there is the issue of the hot cost. Fezolinetant’s list price is currently around $550 per month, and it has received limited insurance coverage so far, according to Forbes. These drugs may eventually be widely covered, especially as they enter the market, but for now, there is a chance that many eligible patients will not be able to afford them.
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