For those struggling with scorching flashes and night sweats, here’s a promising development in menopause treatment. In a phase 3 clinical trial, researchers found that a recent non-hormonal drug, Elinzanetant, could reduce the frequency and severity of vasomotor symptoms in menopausal women.
The often nightmarish discomfort that women go through during menopause includes symptoms such as scorching flashes, heart palpitations, changes in blood pressure, and night sweats. These problems, also known as vasomotor symptoms, result from the narrowing or widening of blood vessels due to decreased estrogen levels during menopause.
Current treatment options often include hormone therapy, but many women shy away from it due to concerns about potential side effects. This is where the importance of recent, effective, non-hormonal treatments comes into play.
Up-to-date test studied the efficacy and safety of Elinzanetant, a nonhormonal drug that blocks chemicals in the brain that cause vasomotor symptoms. Two randomized phase 3 studies conducted by drugmaker Bayer included about 796 postmenopausal participants aged 40 to 65 who were experiencing moderate to severe vasomotor symptoms. The results, published in Jama Network, reveal that Elinzanetant not only alleviated these symptoms but also significantly improved sleep and menopause-related quality of life in these women.
Bayer submitted its study results to the FDA for approval.
“These results have significant clinical implications because vasomotor symptoms often have a significant impact on menopausal individuals’ overall health, activities of daily living, sleep, quality of life, and work productivity,” the researchers wrote in the study published in the journal Jama Network.
During the study, participants received 120 mg of Elinzanetant or placebo once daily for 12 weeks, after which all participants took Elinzanetant for an additional 14 weeks. Participants were asked to record the frequency and severity of vasomotor symptoms at baseline and at weeks 4 and 12.
The researchers observed statistically significant reductions in the frequency and severity of scorching flashes in the first week of both studies. Improvements in sleep quality and overall quality of life were observed at week 12.
“The efficacy in relieving scorching flashes in women with severe symptoms, along with improvements in sleep and mood in multiple studies and elinzanetant’s favorable safety profile, suggest that it has potential as an estrogen-free treatment for women with troublesome menopausal symptoms. Elinzanetant is a dual neurokinin receptor antagonist in the study, meaning that it acts on two receptors in the brain to improve scorching flashes, night sweats, sleep, and overall mood,” said study researcher JoAnn V. Pinkerton, MD, in press release.