Elinzanetant, a (possible) relief for menopausal hot flashes

Women’s health has long been ignored by pharmaceutical research. Not only are they less often included in clinical trials, but many exclusive female conditions are either not or barely researched. One of those is menopause. A change that every woman will experience and that is characterised by a plethora of (unwelcome) symptoms: hot flashes, brain fog, metabolic and sleep changes…

So far, hormonal replacement therapy has been the first (and only) treatment for menopause. However, not all women can or want to undergo this treatment. This may change, according to a new paper ¹ in the Journal of the American Medical Association reporting on the (promising) results of two randomised clinical trials testing a new drug for treating menopausal hot flashes.

The participants in these two phase 3 clinical trials were post-menopausal women 40–65 years old having ≥50 moderate to severe hot flashes over a week. The trial compared the efficacy of elinzanetant to placebo over 26 weeks of treatment. The trial had a treatment group which received the drug for the whole period and a placebo group which received first the placebo and later the drug. This design can be explained by the common observation of a placebo effect in trials testing effects on hot flashes. After one month, most women taking the drug reported ≥50% reduction in the frequency of hot flushes, and by the 3rd month over 70% of women taking elinzanetant reported less hot flashes as well as improved sleep compared to women taking the placebo. What’s more, by the end of the trial, 82% of the participants who took elinzanetant, and >84% of those switched from placebo after 3 months, reported ≥50% reduction in hot flash frequency.

The best thing: this is a non-hormonal drug, which means that, in principle, all women could benefit from its effects. As to why the drug improves sleep while reducing the frequency of hot flashes, it may be because elinzanetant targets a couple of receptors in KNDy neurons, a group of neurons in the hypothalamus involved in temperature regulation and which possibly play a role in insomnia.

The fact that >80% of all participants observed improvements in their symptoms is really good news. Most reported secondary effects were headache and fatigue, which are not so bad under the circumstances. Headache and fatigue were the most commonly reported side effects by participants taking the drug compared with those on placebo. There is a 52-week trial of elinzanetant assessing longer-term safety to further prove the drug’s safety. Hopefully, if the drug is deemed safe, there can be a fast regulatory approval which would enable access to the public.

As a woman who at one point in her life will (hopefully) undergo this life change, I can say that I am happy that finally research is focusing on increasing the quality of life of half, if not more, or the world’s population.