Bayer’s recent announcement about its experimental drug elinzanetant marks a potential breakthrough in menopause treatment, specifically for hot flashes. The drug successfully passed two Phase III clinical trials, positioning it to become the first non-hormonal medication approved globally for treating hot flashes.
This development is significant because it offers an alternative to hormone therapy, which has been the traditional treatment but carries certain risks that have made some women hesitant to use it.
Hot flashes and night sweats, formally known as vasomotor symptoms, affect a significant portion of women during menopause, causing discomfort and potentially leading to other health issues like poor sleep and depression.
While hormone therapy has been effective in managing these symptoms, concerns about its long-term safety, particularly regarding heart disease, breast cancer, and stroke, have reduced its popularity.
Although recent research suggests that these risks might have been overstated and that hormone therapy can be safe for most women, the demand for non-hormonal alternatives has remained high.
For women unable or unwilling to use hormone therapy, options have been limited until recently. Scientific advancements in the early 2010s identified key mechanisms behind hot flashes, leading to the development of drugs targeting specific receptors involved in these symptoms.
Astellas Pharma’s fezolinetant, approved by the FDA in May 2023, was the first drug to treat hot flashes by blocking the NK3 receptor. Bayer’s elinzanetant, which blocks both NK3 and NK1 receptors, builds on this progress by potentially offering a dual-action approach that could also address menopause-related sleep disturbances.
The Phase III trials for elinzanetant included over 700 women and demonstrated significant reductions in hot flashes and improved sleep quality among participants. The drug, taken as a once-daily pill, showed a strong safety profile, with the most common side effects being headaches and fatigue.
Researchers are optimistic that elinzanetant could meet the unmet needs of many menopausal women who suffer from moderate to severe hot flashes, providing a well-tolerated non-hormonal treatment option.
However, despite the promising results and the likely approval of elinzanetant, there is concern about the cost of these new treatments. For example, fezolinetant, another drug in the same class, is priced at around $550 per month and has limited insurance coverage, which could restrict access for many women.
As more of these drugs enter the market, insurance coverage may improve, but the high cost remains a significant barrier for now.
