A groundbreaking new drug, elinzanetant, may offer significant relief for women suffering from hot flashes and other menopausal symptoms, according to recent research. The drug demonstrated a notable reduction in hot flash frequency and severity in clinical trials.
Elinzanetant, a drug currently under development, was shown to reduce the frequency of hot flashes by an average of 56% after one month and more than 65% after three months of use. In trials involving over 300 postmenopausal women, approximately 62% experienced at least a 50% reduction in hot flash frequency. The findings were published in the Journal of the American Medical Association and funded by Bayer, the drug’s manufacturer.
Dr. JoAnn Pinkerton from the University of Virginia Health led the study. According to her team, hot flashes, also known as menopausal vasomotor symptoms (VMS), affect up to 80% of women during menopause and can persist for several years. The new drug not only reduced the frequency of these symptoms but also their severity.
Historically, hormone replacement therapy (HRT) was commonly used to alleviate hot flashes. However, concerns over increased risks of breast cancer and stroke have led many women to avoid HRT. While certain SSRIs (selective serotonin reuptake inhibitors) can offer relief, they are not suitable for everyone due to side effects and contraindications.
Elinzanetant belongs to a new class of non-hormonal drugs known as neurokinin (NK)-3 receptor antagonists. These drugs target KNDy neurons, which are involved in the body’s thermoregulation. Overactivity of these neurons is thought to disrupt normal temperature regulation, triggering hot flashes.
The study involved two phase 3 clinical trials, each including over 300 women aged 40 to 65 who suffered from moderate to severe hot flashes. Participants were randomly assigned to receive either elinzanetant (120 milligrams) or a placebo daily for 26 weeks.
At the start of the trials, participants reported an average of 14 hot flashes per day. By week 4, the average number of daily hot flashes had decreased to fewer than 8 for those on the placebo and fewer than 6 for those taking elinzanetant. By week 12, women taking elinzanetant experienced a reduction to approximately 4.7 hot flashes per day—a 65% decrease from the study’s beginning. Additionally, those on elinzanetant reported less severe hot flashes and improved sleep quality.
While the drug showed significant benefits, some participants experienced mild side effects, including headache and fatigue. According to Dr. Stephanie McNally from Northwell Health’s Katz Institute for Women’s Health, this new treatment offers hope for women who cannot use hormonal medications due to medical conditions or personal preferences.
Drs. Stephanie Faubion and Chrisandra Shufelt of the Mayo Clinic highlighted that drugs targeting the NK-3 receptor, such as fezolinetant (which gained FDA approval in 2023), are already making waves in treatment. They speculate that these drugs could potentially improve sleep and prevent menopause-associated weight gain around the abdomen.
The promising results from elinzanetant trials represent a significant advancement in menopause care. With new non-hormonal options becoming available, the management of menopausal symptoms is likely to improve, offering relief to many women who have long struggled with these challenging symptoms.
The new drug’s application for FDA approval marks a critical step forward, potentially expanding the arsenal of treatments available for menopausal women and enhancing their quality of life during this transitional phase.
