NEW YORK (HealthDay News).—A drug developing could offer a much-needed option for women seeking relief from hot flashes and other menopause symptomsaccording to recent research.
The drug, elinzanetant, reduced the frequency of hot flashes by an average of 56% after one month of use and by more than 65% after three months.
Overall, about 62 percent of 300 postmenopausal women in two trials experienced “at least a 50 percent reduction in (hot flash) frequency,” wrote a team led by Dr. JoAnn Pinkerton of University of Virginia Healthen Charlottesville.
The drug also appeared to decrease the severity of hot flashes.
The two trials were funded by elinzanetant’s manufacturer, Bayer, and were published in the Journal of the American Medical Association.
Based in part on these results, the company announced earlier this month that it had filed a new drug application for elinzanetant with the Food and Drug Administration (FDA) from the United States.
According to the team Pinkertonup to 80% of women will experience hot flashes, medically known as menopausal vasomotor symptoms (VSM), during menopause and sometimes last for many years.
Hot flashes can be debilitating and difficult to predict, and there are few therapeutic options to treat them.
Hormone replacement therapy was found decades ago to decrease the severity of hot flashes, but later studies linked it to an increased chance of breast cancer and stroke, and many women now avoid the treatment. Some SSRI antidepressants They can help some patients.
However, “many women have contraindications, have tolerability issues that lead to discontinuation, or prefer not to take these treatments,” the study authors noted.
He fezolinetant (Veozah)the first in a new class of non-hormonal medications called hormone receptor antagonists. neuroquinina (NK)-3gained FDA approval in 2023 for the treatment of moderate to severe hot flashes.
This class of drugs targets a specific type of brain cell called KNDy neuronswhich is known to be involved in “thermoregulation” of the body.
The hyperactivity of KNDy neurons “It has been linked to disruption of thermoregulation, which could trigger VMS,” they explained. Pinkerton and his collaborators. Elinzanetant targets this mechanism to relieve hot flashes.
The new study includes findings from two Phase 3 clinical trials, each involving 300 postmenopausal women ages 40 to 65 (average age was about 55). All had experienced moderate to severe hot flashes. The women were randomly given elinzanetant (120 milligrams) or a “dummy” placebo pill daily for 26 weeks.
The placebo effect is powerful, so women on either regimen saw some reduction in the frequency and severity of hot flashes.
However, women taking elinzanetant got significantly more relief.
At the beginning of the trials the average participant said she suffered 14 hot flashes per 24-hour period.
However, by week four of one of the trials that number had dropped to less than 8 per day among women taking the placebo, and to less than 6 per day among those taking elinzanetant.
By week 12, daily hot flashes had dropped to fewer than 8 per day for women taking placebo and just 4.7 per day for women taking elinzanetant.
This last figure represents the 65% reduction in the frequency of hot flashes compared to the beginning of the trial.
Hot flashes also tended to be less severe for those taking elinzanetant, the participants said. Women taking the drug reported significant improvement in sleep.
At the end of both 26-week trials, “more than 80 percent of participants had achieved at least a 50 percent reduction” in the frequency of hot flashes, the researchers said, suggesting that the benefits were sustained. long term.
As for side effects, about half of the participants complained of problems such as headache or fatigue, Pinkerton’s group said. “Most events were mild in intensity and none were serious,” they noted.
“For women who can’t take hormonal medications, whether due to medically driven comorbidities, cardiovascular disease, hormone-responsive cancers, or other reasons, this really provides an area of hope and positivity so that women don’t have to suffer. ” said Dr. Stephanie McNally, director of obstetrics and gynecology services at Northwell Health’s Katz Institute for Women’s Health in Garden City. New York. He did not participate in the new investigation.
Writing in a journal editorial that accompanied the study, two other experts said these drugs are already entering mainstream practice, with fezolinetant appearing in ads aired during this year’s Super Bowl.
Las doctors Stephanie Faubion and Chrisandra Shufelt, from the Mayo Clinicnoted that drugs targeting the (NK)-3 receptor have already been shown to be effective in relieving insomnia.
Therefore, medications like elinzanetant “could work synergistically to inhibit (hot flashes) and improve sleep,” they theorized.
There’s even a hint from early research that inhibiting the (NK)-3 receptor might prevent the excess fat deposits around a woman’s waist that can come with menopause. So drugs like fezolinetant and elinzanetant “could also potentially inhibit the known increase in visceral fat associated with the menopause transition,” Faubion and Shufelt reasoned.
The conclusion: “With the discovery of non-hormonal treatment options targeting the neurons responsible for VMS, menopause care should advance on this solid scientific basis to benefit affected people,” the two experts wrote.
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