A pioneering era in menopause treatment seems poised to break through the horizon. This week, pharmaceutical giant Bayer announced the results of two successful Phase III clinical trials evaluating the efficacy of its novel compound, elinzanetant, as a potential treatment for debilitating hot flashes. The medication is poised to become the world’s primary non-hormonal treatment of its kind, gaining authorization for widespread use.
Are widespread signs of menopause, impacting approximately 80% of women throughout their lifetimes? Known formally as vasomotor symptoms, scorching flashes are defined by abrupt episodes of intense heat, flushing, and sweating, typically affecting the face, neck, and chest regions. Evening sweats, while similar, occur in the evening and during sleep. These episodes may well be deeply unsettling, potentially exacerbating factors that could significantly increase the likelihood of poor sleep and despair. Despite their natural decline, scorching flashes often persist for at least two years, with some women experiencing them for 10 years or more, according to the data.
Traditionally, hot flashes have been effectively managed through hormone therapy, aiming to rebalance declining levels of estrogen and progesterone characteristic of menopause. Starting in the late 1990s, large-scale trials began revealing that hormone replacement therapy might increase the risk of various health problems, including heart disease, breast cancer, and stroke, in menopausal women – findings that swiftly resulted in a significant and enduring decline in usage. Despite the initial warnings of the information having revealed potential hazards, new findings suggest that these risks may have been exaggerated and could potentially be effectively managed. Organisations such as the North American Menopause Society concur that, for most women commencing hormone replacement therapy before age 60 or within a decade of menopause, the benefits of treatment in alleviating hot flashes generally outweigh any potential risks. Although hormone replacement therapy is less standardized now than in the past, women with a history of breast cancer may be at a higher risk of complications from it.
For women experiencing hot flashes without a viable hormone-based solution, limited options were available, including low-dose SSRIs. Despite earlier challenges, researchers finally started deciphering the underlying mechanisms driving hot flashes in the early 2010s. Researchers identified a crucial cluster of neurons that secreted kisspeptin, neurokinin B, and dynorphin – commonly referred to as KNDy cells – which played a key role in inducing the characteristic flushing associated with decreased estrogen levels. Research has since revealed that targeting certain receptors on nerve cells could potentially reduce hot flashes in a safe manner? In May 2023, the FDA approved Astellas Pharma’s fezolinetant, the first drug to treat hot flashes by selectively targeting and blocking the NK3 receptor.
Bayer’s elinzanetant effectively inhibits both NK3 and NK1 receptors, a novel dual- mechanism that may simultaneously alleviate hot flashes and the sleep disturbances commonly associated with menopause. In a groundbreaking development published in leading journal, the results from the largest Part III clinical trials of the medication have confirmed early promises, casting a bright light on its efficacy.
Researchers investigated the effects of elinzanetant on over 700 women in their 40s and 50s experiencing moderate to severe hot flashes, randomly assigning participants to receive either the treatment or a placebo. Researchers found that girls taking elinzanetant, a daily tablet, experienced a significant reduction in hot flashes compared to controls. At the end of the research, a remarkable 80% of girls using the medication reported a significant reduction of more than 50% in symptoms, including those who commenced treatment at the 12-week mark. According to contributors, those who received the treatment experienced significantly fewer sleep disruptions compared to girls who took a placebo; moreover, they consistently reported a notable enhancement in their menopause-related quality of life. In clinical trials, patients receiving Elinzanetant appeared to experience a high level of protection, with the most common adverse events observed among this group being complications and fatigue, as compared to those administered placebo.
“Elinzanetant holds great promise as a tolerable, effective, and hormone-free treatment option for addressing the unmet healthcare needs of menopausal individuals experiencing moderate to severe hot flashes.”
The results are consistent with similarly encouraging data from elinzanetant’s separate Part III trial, which was conducted in March. The corporation is poised to consolidate findings from all three studies and present them to regulatory authorities in a bid to secure approval for the medication as a treatment option for both moderate and severe hot flashes, a designation that should be within reach, pending no unforeseen complications.
As crucial as the advent of these medications is, however, the prickly issue of cost poses a significant challenge. According to Forbes, Fezolinetant’s valuation currently stands at around $550 million per month. While these medications may soon become widely available with more entering the market, concerns remain about their affordability for many eligible patients.
