This non-hormonal drug safely reduces hot flashes during menopause for up to six months.
He fezolinantant He only non-hormonal pharmacological treatment for the treatment of moderate to severe vasomotor symptoms (hot flashes and night sweats) associated with menopause. A year ago, it became the first neurokinin 3 receptor antagonist ( … NK3) has been approved by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of these menopausal symptoms. It has been available in Spain since the beginning of May.
A study presented this Friday at the 26th European Congress of Endocrinology in Stockholm confirmed that fezolinetant reduces the frequency and severity of hot flashes during menopause for 24 weeks, no serious side effects. These results provide further evidence of the benefits of using this non-hormonal preventive medication in women experiencing hot flashes during menopause.
Hot flashes and night sweats affect up to 80% of menopausal women and can significantly affect daily life, exercise and sleep. Hormone replacement therapy (HRT) is the most effective treatment, but these drugs are not indicated for some women, such as endocrine cancer survivors or those with untreated high blood pressure. Others choose not to take them in the first place because of the potential side effects.
This new type of non-hormonal drug has the advantage that acts directly on the temperature regulation pathway and relieves these symptoms. Specifically, it blocks the brain protein neurokinin-3 (NK-3), which is involved in regulating body temperature. But unlike estrogen replacement hormone therapy, fezolintantant will not relieve other symptoms menopause, such as mood changes or vaginal dryness.
Previous late-stage clinical studies (SKYLIGHT 1 and SKYLIGHT 2) showed that fezolinetant reduced both the frequency and severity of hot flashes in women with moderate to severe symptoms compared with placebo over 12 weeks. This phase 3b study, known as DAYLIGHT and supported by Astellas Pharma, examined the effect of fezolinetant over 24 weeks.
Researchers studied 453 menopausal women aged 40 to 65 years. with moderate to severe hot flashes who were not eligible for hormone replacement therapy after receiving 45 mg of fezolinetant or placebo, and found that women taking fezolinetant had less frequent and severe hot flashes over 24 weeks.
Women taking fezolinetant experienced fewer hot flashes in the first week, with the greatest reduction during the first 3 days. Their severity also decreased sharply when taking the drug in the first week from the second day. No safety concerns were identified with fezolinantate 45 mg for 24 weeks.
“DAYLIGHT is the first study of fezolinetant to examine placebo-controlled efficacy over 24 weeks,” says Professor Antonio Cano from the INCLIVA Research Institute in Valencia, Spain, who was involved in the study.
The expert assures that fezolintant “was effective and well tolerated for 24 weeks. Moreover, the effect was observed already from the 1st day of treatment. “Although there are other NK antagonists, none have shown similar concordance of efficacy and safety in clinical trials with large enough numbers of participants,” he adds.
However, Professor Cano reminds that these symptoms vary in prevalence or intensity depending on ethnic background (for example, SMS is more frequent and severe in black women), so “more clinical data are needed in different populations or geographic regions of the world.” “.