comscoreHormone-Free Medicine for Hot Flashes Shows Promise

Hormone-Free Medicine for Hot Flashes Shows Promise

Fezolinetant, an experimental medicine that doesn’t contain hormones, has successfully treated hot flashes.
Jun 22, 2022.
 

Fezolinetant, an experimental medicine that doesn’t contain hormones, has successfully treated hot flashes, according to a study.

The research was presented on June 11, 2022, at ENDO 2022, the annual conference of the Endocrine Society. Read the abstract of “(OR06) Fezolinetant for Treatment of Moderate-to-severe Vasomotor Symptoms Associated with Menopause: Results from a 52-week Study (Skylight 2)” (scroll to OR06, 12:30 session or search "fezolinetant").

 

About hot flashes

Hot flashes and night sweats — called vasomotor symptoms by doctors — happen to many post-menopausal women. If you’re diagnosed with breast cancer before menopause, some treatments, including chemotherapy and hormonal therapy medicines, can bring on menopause earlier and more abruptly than usual. Also, the hot flashes and night sweats that accompany menopause caused by breast cancer treatment can be more intense and last longer.

For some women, these symptoms can be severe, dramatically affecting their quality of life, including how well they sleep.

In search of relief, some women consider hormone replacement therapy (HRT), which can help ease hot flashes and night sweats. But because HRT contains estrogen or a combination of estrogen and progesterone, which can make breast cells grow, it is not recommended for women who have been diagnosed with breast cancer.

So researchers have been looking for other ways to control menopausal symptoms without having to use hormones.

 

About fezolinetant

Experimental fezolinetant is a type of medicine called a selective neurokinin-3 receptor antagonist. Research suggests that when the neurokinin B protein attaches to the neurokinin 3 receptor, it can play a role in triggering hot flashes. Fezolinetant blocks the neurokinin B protein so it can’t attach to the neurokinin-3 receptor, which researchers think might ease the severity and frequency of hot flashes, based on small, early studies. Fezolinetant is especially important for women who’ve been diagnosed with breast cancer because it doesn’t contain hormones.

Fezolinetant is a pill taken by mouth.

 

About the study

In this multinational study called SKYLIGHT 2, the researchers wanted to see if fezolinetant could ease hot flashes and night sweats and improve sleep in post-menopausal women.

The study included 484 post-menopausal women ages 40 to 65 who were having seven or more hot flashes per day. It’s not clear if any of the women had ever been diagnosed with breast cancer.

The study was made up of two parts. In the first part, the researchers randomly assigned the women into one of three treatment groups. The women in each group took one of the following pills every day for 12 weeks:

  • 30 milligrams of fezolinetant

  • 45 milligrams of fezolinetant

  • a placebo, a pill that contained no medicine, but looked just like the fezolinetant pills

After 12 weeks, the researchers randomly reassigned the women taking the placebo into a fezolinetant treatment group, so they took either 30 milligrams or 45 milligrams of fezolinetant for 40 weeks. The women who took fezolinetant for the first 12 weeks continued to take the same dose for another 40 weeks. So overall:

  • 166 women took 30 milligrams of fezolinetant for 52 weeks

  • 167 women took 45 milligrams of fezolinetant for 52 weeks

  • 76 women took a placebo for 12 weeks and 30 milligrams of fezolinetant for another 40 weeks

  • 75 women took a placebo for 12 weeks and 45 milligrams of fezolinetant for another 40 weeks

After the first 12 weeks, the researchers wanted to see if fezolinetant eased the frequency and severity of hot flashes and night sweats and improved sleep more than the placebo.

Women taking either dose of fezolinetant reported they had less frequent and less severe hot flashes and night sweats than the women taking the placebo. Women taking fezolinetant also reported better sleep than women taking the placebo.

All these differences were statistically significant, which means they were likely because of the differences in medicine and not just due to chance.

The improvements in hot flashes, night sweats, and sleep continued through the end of the study for the women who took either dose of fezolinetant the entire time.

Women who took the placebo first and then took fezolinetant the rest of the time:

  • had reductions in the severity and frequency of hot flashes after switching that were similar to women who took fezolinetant the entire time

  • reported better sleep after switching

Fezolinetant didn’t cause any serious side effects. The most common side effect of fezolinetant was headache.

In an interview, presenter Genevieve Neal-Perry, MD, PhD, distinguished professor and chair of obstetrics and gynecology at the University of North Carolina School of Medicine, said that fezolinetant would be particularly beneficial for women who can’t take HRT for hot flashes, such as women who’ve been diagnosed with breast cancer or blood-clotting disorders.

“If the drug is approved, I’m excited about it,” Dr. Neal-Perry said. “There hasn’t been a lot of focus . . . on hot flashes. It’s something that women are just expected to live through.”

 

What this means for you

If you’re having hot flashes or night sweats as a result of breast cancer treatment-induced menopause, the results of this study are very exciting.

Still, it’s important to know that the U.S. Food and Drug Administration (FDA) has not approved fezolinetant, and it’s not clear when Astellas, the company that makes fezolinetant, might apply for FDA approval.

In the meantime, there are other techniques, such as mindfulness meditation and yoga, that have been shown to ease hot flashes.

Learn more about Managing Hot Flashes Naturally and Hot Flash Medications for Women With Breast Cancer.

Written by: Jamie DePolo, senior editor

— Last updated on August 5, 2022, 7:42 PM

Reviewed by 1 medical adviser
 
Brian Wojciechowski, MD
Crozer Health System, Philadelphia area, PA
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