Experimental menopause drug cuts number of hot flushes

Phase II study reports significant reduction in menopausal symptoms in women who took neurokinin 3 receptor antagonist MLE4901.

Hot flush woman fanning

An experimental drug has been shown to dramatically cut the number of hot flushes in women with severe menopause symptoms.

In a phase II randomised trial of the neurokinin 3 receptor antagonist MLE4901 in 28 women aged 40-62 years who had seven or more hot flushes a day, a significant reduction in symptoms was found in women who took the drug.

MLE4901 cut the frequency of flushes by 45 percentage points, and symptom severity by 41 percentage points, between the week before the study began and week four of treatment.

The trial was designed as a placebo-controlled crossover study, so women taking part took the test drug followed by placebo, or placebo followed by the test drug, and acted as their own controls. The research team at Imperial College London, which conducted the study, said the treatment seemed to be “pretty life-changing”.

Women experienced a 73% drop in symptom frequency compared with baseline levels when taking MLE4901 – which works to block the action of neurokinin B, a chemical implicated in menopausal flushing. Meanwhile, women taking the placebo pills experienced a 28% reduction in symptom frequency.

The study, which was funded by the UK Medical Research Council and the National Institute for Health Research, and published in The Lancet
, also showed the drug — originally developed by AstraZeneca — reduced the impact of flushes on participants’ daily life.

Professor Waljit Dhillo, an NIHR research professor from the Department of Medicine at Imperial College London, says the drug could be a “game-changer” for women having more than seven hot flushes a day.

“For day-to-day living and work, that’s a significant impact on quality of life.”

Women taking part in the trial said they felt “human again”, says study leader Julia Prague. “Despite the fact that for millions of women their menopausal symptoms are intolerable, so many are suffering in silence because it is a taboo subject and treatment options are limited.”

Once the drug is tested in a larger study, it is hoped to become an alternative for hormone replacement therapy, which some patients are advised against taking because of the increased risk of breast cancer and blood clots.

Professor Mary Ann Lumsden, senior vice president of the Royal College of Obstetricians and Gynaecologists, says that the study is welcome news for women going through the menopause, but “it is a relatively small trial and further research is needed”.


[1] Prague K, Roberts R, Comninos A et al. Neurokinin 3 receptor antagonism as a novel treatment formenopausal hot flushes: a phase 2, randomised, double-blind, placebo-controlled trial. The Lancet doi: 10.1016/S0140-6736(17)30823-1

Last updated
The Pharmaceutical Journal, Experimental menopause drug cuts number of hot flushes;Online:DOI:10.1211/PJ.2017.20202572

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