US women will be able to access the first drug against menopausal hot flashes

Uncomfortable, unexpected…. A rise in body heat that can end in an exaggerated flushing or sweating and even end in a picture of chills. Hot flashes alter the quality of life of women walking from their fertile stage to menopause. This alteration of the quality of life had no other relief than looking for a fan or a place to “hide” to pass the “bad time”.

For a few days, in the US women will have another option: a drug called fezolinetant. The current one is based on estrogen supplementation, but some women do not accept it and, in cases such as breast cancer survivors, they cannot afford.

“In this case, the product that has been approved by the FDA provides us with one more tool to add to our therapeutic arsenal, for the health care of a large percentage of women who for various reasons cannot benefit from hormone therapy for menopause”, explains María Fasero, spokesperson for the Spanish Association for the Study of Menopause (AEEM)..

Hot flashes are perceived by up to 80% of women and that in around 25% they are frequent and severe. They are not only suffered by women in menopause, but also by others with a special risk profile, such as breast cancer survivors who receive hormone cancellation treatment..

Fasero, coordinator and founder of the Healthy Menopause Unit of the Hospital de la Zarzuela, regrets that there is still time for this new resource to reach Europe and even more so Spain. “There are still many barriers that you have to go through. For a product to be marketed in Spain, it must pass the approval of the EMA (European Medicines Agency), which is expected by the end of the year. Then, that it be given the green light in Spain by the Aemps (Spanish Agency for Medicines and Health Products). So there is still a long way to go before it is commercialized here”.

How does the anti-hot flash drug work?

Neurokinin 3 is a small protein that acts as a stimulant for neurons, the cells of the central nervous system.. At the brain level, in a region known as the hypothalamus, its production is regulated by estrogens, the female ovarian hormones.. When the ovary stops working, there is an overproduction of neurokinin 3, which excites the neurons responsible for maintaining temperature control.. This is when the high comes.

The result is a sudden sensation of heat, which can appear with more or less frequency or intensity, and which, in some women, interferes with sleep, work productivity and other activities of daily life.. In women where this problem is particularly acute, such as those subjected to intense ovarian deprivation due to diseases such as breast cancer, the series of hot flashes, frequent and intense in some cases, becomes a determinant of suffering added to that of the disease.

Fasero scores the precise use of this new therapy. “I think effective treatment of some menopausal symptoms, such as hot flashes in this case, should not be confused with the use of menopausal hormone therapy.. This therapy encompasses and treats many other symptoms that alter the quality of life of women in menopause, so I believe that comparisons cannot be made”.

For this reason, the expert specifies that “the indication for the treatment of hot flashes can be equated to menopausal hormone therapy”. But it is not like that, “this product goes on the market with the indication of the treatment of vasomotor symptoms in those women who do not want or cannot receive menopausal hormone therapy”.

Regarding the time of use, Fasero details that “although the clinical trials that fezolinetant has are for 52 weeks, in normal clinical practice, it could be used for the entire time that the vasomotor symptoms last in women”.

Are there risky side effects?

New molecules are always accompanied by shadows that can condition their use before their administration.. “The origin of fear about liver damage dates back to 2017, when, as a result of a clinical trial on a molecule with a similar mechanism of action, called Pavinetant, it had to be interrupted due to potential harmful effects on the liver,” recalls Fasero..

In the case of this new molecule, “it has been shown to be a safer molecule; however, due to this alarm, it is recommended that women who start this treatment undergo an analysis to assess liver function and a quarterly control at the beginning during the first nine months of use of the drug”. And the coordinator of the Hospital de La Zarzuela continues with the explanation, “probably this alarm can be eliminated with the use of the product in normal clinical practice, but the safety of the woman must always prevail, so being cautious is always correct”.

A drug already tested by Spanish women, but in clinical trials

The INCLIVA Health Research Institute, of the Hospital Clínico de València, participated in international research for the clinical development of new drugs to alleviate the effects of hot flashes from which these results are derived, recently published in The Lancet.

The AEEM spokeswoman explains that “the information from the clinical trials that we have makes us think that it is a very effective drug for the treatment of hot flashes, that it acts very quickly (its effect can be noticed in a week ) and above all that they do not act at the level of estrogen receptors. This is important for a large percentage of women who do not want treatment for hot flashes because they are afraid of hormones.”.

Other future options still in the test lab

Fasero assures that in the future there will be more news. “Probably by finding the origin of hot flashes at the CNS (central nervous system) level; pharmacological novelties are focused on research on these substances that transmit information. In fact, there are already clinical trials of other substances similar to fezolinetant, such as elinzanetant, whose action is double, since in addition to acting on the neurons that transmit the impulse of hot flashes, it seems that it could act on the neurons that transmit the information mood and sleep, two symptoms that are also very common in menopausal women”.

It also mentions that “new clinical trials to expand fezolinetant are being developed, such as the Daylight study in women for whom menopausal hormone therapy is contraindicated.”.

Living with the side effects of menopause

Among the range of symptoms of menopause, hot flashes are one of the most prevalent and with the greatest negative impact on work activity and on the quality of life in general.. But we must not forget that routines are also altered by mood swings, sleep disturbances, headaches and joint pain, among others..

From the Spanish Society of Gynecology and Obstetrics they point out that this period varies from one woman to another and the pattern also differs. They can be suffered from two and three years before menopause to five years after.

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