Bayer has reported promising results from two new trials of an experimental drug called elinzanetant, which offers a once-a-day, non-hormonal treatment for hot flashes associated with menopause. The trials demonstrated that elinzanetant significantly reduced the frequency and intensity of hot flashes and improved sleep compared to a placebo.
This new medication targets brain chemicals involved in hot flashes and night sweats, providing a potentially valuable option for women experiencing menopausal symptoms.
Elinzanetant functions by blocking specific brain chemicals responsible for vasomotor symptoms, which are common during menopause due to reduced estrogen and progesterone production. This phase of life typically occurs in women in their 40s or 50s and can lead to various symptoms such as mood swings, brain fog, and insomnia.
The new drug provides a non-hormonal alternative to manage these symptoms, unlike hormone replacement therapy (HRT), which has fallen out of favor due to associated health risks.
Hormone replacement therapy was widely used in the 1990s, but a major study revealed increased risks of heart disease and cancer, leading to a sharp decline in its use. Despite recent studies indicating that HRT may be safer when used close to menopause and for shorter durations, many doctors remain cautious.
Non-hormonal options like elinzanetant and fezolinetant (another newly approved drug) are particularly beneficial for women who cannot use hormones, such as those with hormone-sensitive cancers.
The new drugs, including elinzanetant and fezolinetant, work by targeting a newly understood pathway in the brain that regulates hot flashes. These medications block neurokinins, which are chemicals that become overly active during menopause and trigger hot flashes.
This approach not only addresses hot flashes but might also impact related symptoms such as mood changes and sleep disturbances, although further research is needed.
In the trials, women who took elinzanetant reported a significant reduction in the number of hot flashes and improved sleep compared to those on a placebo. After 12 weeks, participants taking the drug experienced about 10 fewer hot flashes daily, compared to a reduction of seven in the placebo group.
Over 80% of women taking elinzanetant saw at least a 50% reduction in their hot flashes, and the drug’s side effects were generally mild, including headaches and fatigue.
Bayer has submitted the study data to the FDA for approval, and while the results are promising, the accessibility of elinzanetant will be a key factor in its adoption. As Dr. Stephanie Faubion notes, more treatment options for menopausal symptoms are beneficial, but the cost and insurance coverage for new medications like elinzanetant remain important considerations for many women.
