An experimental pill cut hot flashes and improved sleep for women in menopause — without using hormones

CNN — Two new trials from drugmaker Bayer show that an experimental once-daily medication that functions without hormones considerably reduced the amount of hot flashes experienced by women going through menopause and improved their sleep compared to a placebo.

The medication, known as elinzanetant, acts by preventing the brain chemicals that cause vasomotor symptoms, such as hot flashes and night sweats, in women whose ovaries have decreased their synthesis of progesterone and oestrogen. This initiates the menopause, a stage of life that often occurs in a woman’s 40s or 50s.

Fezolinetant, also marketed as Veozah, is a comparable medication that was licensed by the US Food and Drug Administration last year.

These medications offer women new choices during a stage of life when their bodies are acclimating to a new hormonal normal. A wide range of symptoms, such as mood swings, cognitive fog, changes in libido, and insomnia, can accompany this transformation.

Some women find the symptoms annoying, but they don’t get in the way of their everyday life. However, for others, they can be crippling, and many medical professionals are hesitant to recommend hormone replacement medication, the conventional treatment, out of concern that it may raise the risk of heart disease, cancer, and stroke.

The director of the Mayo Clinic Centre for Women’s Health, Dr. Stephanie Faubion, stated that “very few women get any sort of help.”

According to Faubion, hormone replacement therapy, or HRT, was used by about 40% of postmenopausal women in the 1990s, when it was at its peak. However, the usage of hormones for menopausal symptoms dropped to roughly 4% after a significant government research linked the use of HRT for women to an increased risk of cancer and heart disease, according to Faubion’s commentary on the studies.

Though many medical professionals are still dubious, more recent research—including many reexaminations of the government trial data—has demonstrated that HRT is not associated with higher health risks for women when taken sparingly and in the period immediately preceding menopause.

Furthermore, hormones are not recommended for menopausal relief in survivors of hormone-sensitive malignancies, such as certain types of breast cancer. According to Faubion, who did not participate in the recent research, the new non-hormonal medications are excellent choices for them. The medication, Veozah, which has already received approval, is pricey. At $550 per month on the list, Veozah is expensive and not all insurers are willing to cover it. The manufacturer of elinzanetent, Bayer, has not disclosed the price it will charge for the medication.

According to Faubion, she has attempted to prescribe Veozah to a few patients, but their insurance companies insisted that they try at least two less costly drugs prior to paying for the prescription.

They need to clear hurdles. And I’ve already prescribed it,” Faubion remarked. She is unsure if her patients ingested the Veozah. “I’m not sure if they gave up before they received the prescription or if they actually received it.”

Elinzanetant and fezolinetant are two of the first medications to target a recently identified brain mechanism that seems to regulate hot flashes.

The hypothalamus, a tiny, almond-sized area deep within the brain that, among other things, aids in controlling the body’s temperature, has nerves that become hyperactive as oestrogen levels drop during menopause. This results in an excess of chemical signals known as neurokinins. The two novel medications inhibit the openings on cells where specific neurokinins attach, so reducing their capacity to activate the brain and induce hot flashes.

The fact that these neurones are connected to mood, food, and sleep makes them extremely fascinating. And as is well known, this is a broad summary of midlife issues affecting women. They’re gaining weight, not sleeping, having hot flashes, and having a bad mood, according to Faubion. It’s unclear at this time if focussing on those neurones could assist with issues other than hot flashes.

Hot flashes are precisely what they sound like: an intensely hot flash that typically occurs in the head, chest, and face. Additionally, it may result in severe flushing and perspiration that lasts for several minutes. This is referred to as a “night sweat” when it occurs at night. These can be very disruptive and occur infrequently or frequently in women going through the menopause.

The two related trials, which were published on Thursday in JAMA, involved over 400 women who had moderate to severe symptoms. The researchers classified this as experiencing more than 50 hot flashes per week, with an average of 14 to 16 per day.

Half of the women in each trial received the experimental medication from the researchers, while the other half received a placebo, which has no effect. Who was taking the medication or the placebo was a secret to both the women and the researchers. The women documented their symptoms in daily diaries. The women who received the placebo were moved to the study treatment after 12 weeks, and they continued to take it for an additional 14 weeks.

After four weeks, women taking elinzanetant reported around eight fewer hot flashes per day, or roughly half as many as they had before the study began, compared to about four less hot flashes per day, or roughly one-third fewer, for women taking a placebo. Since the difference was statistically significant, it seemed unlikely to be the result of random variation. After a 12-week period, women taking elinzanetant reported experiencing an average of 10 fewer hot flashes per day, while the placebo group saw an average change of roughly seven hot flashes per day. In addition to reporting greater sleep, those on the medication said their hot flashes were milder.

Over 80% of the women in the 26-week research who used elinzanetant reported at least a 50% decrease in hot flashes by the end of the trial. Because the two trials’ outcomes were so comparable, the researchers felt confident in their findings.

Headaches and exhaustion were the most frequent adverse effects experienced by female patients.

Bayer announced recently that it has already sent the FDA the trial results for clearance.

It appears to be a very promising medicine, according to Faubion. It is unclear how accessible it will be.

According to Faubion, “more options for women are a good thing.”