For those struggling with hot flashes and night sweats, here's a promising development in menopause treatment. In a phase 3 clinical trial, researchers have found that the new 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 like hot flashes, heart palpitations, changes in blood pressure, and night sweats. These issues, also called vasomotor symptoms, arise from the constriction or dilation of blood vessels due to decreased estrogen levels during menopause.
The current treatment options often involve hormone therapy, but many women avoid it due to concerns about potential side effects. This is where the significance of a new, effective, non-hormonal treatment comes into play.
A new study investigated the efficacy and safety of Elinzanetant, a non-hormonal drug that blocks the brain chemicals responsible for vasomotor symptoms. Two randomized phase 3 trials, conducted by the drug manufacturer Bayer, involved around 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 has submitted its study data to the FDA for approval.
"These results have clinically relevant implications because vasomotor symptoms often pose significant impacts on menopausal individual's overall health, everyday activities, sleep, quality of life, and work productivity," the researchers wrote in the study published in Jama Network.
During the trial, the participants either received 120 mg of Elinzanetant or a placebo once daily for 12 weeks, after which all the participants took Elinzanetant for an additional 14 weeks. The participants were asked to record the frequency and severity of vasomotor symptoms at baseline and weeks 4 and 12.
The researchers observed statistically significant reductions in the frequency and severity of hot flashes within the first week in both trials. Improvements in sleep quality and overall quality of life were seen by week 12.
"The effectiveness for relief of hot flashes in highly symptomatic women, along with improvements in sleep and mood across multiple trials and favorable safety profile of elinzanetant, suggests it has potential as a non-estrogen treatment for women with bothersome menopausal symptoms. Elinzenetant is a dual neurokinin receptor antagonist in testing, meaning it works on two receptors in the brain to improve hot flashes, night sweats sleep, and overall mood," researcher Dr. JoAnn V. Pinkerton said in a news release.
