The FDA approved a new drug for hot flashes. Here’s why it shows ‘a lot of promise’

Hanna Webster | Pittsburgh Post-Gazette

The Food and Drug Administration last Friday approved fezolinetant, or Veozah, to treat hot flashes for women in menopause. The non-hormonal drug treatment is the first of its class and represents an option for women who cannot take hormones.

Menopause occurs when women do not get a period for 12 consecutive months, usually beginning between ages 45 and 55. Hot flashes are the most common menopausal symptom and can interfere with quality of life. Of those in menopause, more than 80% of them suffer from hot flashes.

More women are entering menopause as well, as people are living longer and the substantial Gen X generation ages into menopause.

“It’s great that this is going to market,” said Dr. Beth Prairie, an OBGYN and preventive medicine physician at Allegheny Health Network Midlife Women’s Associates and the chief medical officer of West Penn Hospital. Dr. Prairie has specialized in menopausal medicine for more than 15 years and said the approval of Veozah will open up a whole new possibility for patients who cannot benefit from hormone therapy.

Veozah, from Japan-based Astellas Pharma, is part of a class of medications called NK3 antagonists — NK3 is a kind of receptor that controls brain cells called KNDy neurons. When women age and estrogen levels plummet, NK3 goes into overdrive, said Dr. Katherine Scruggs, an OBGYN at the University of Pittsburgh Department of Women’s Health. The body thinks it’s hotter than it is, so it responds accordingly, leading to hot flashes.

Veozah can stop this pathway by blocking receptors in the brain’s hypothalamus, a region that keeps body temperature in check.

Research has shown that the hypothalamus is implicated in hot flashes. KNDy neurons, which live in the hypothalamus, act like switches for hot flashes. When a patient takes a Veozah pill, it blocks KNDy neurons from firing, thus stopping hot flashes.

During a hot flash, in addition to a sudden feeling of warmth, women may experience sweating and reddened skin.

It was only 10 years ago when women scientists discovered how hot flashes happened in the body, said Dr. Prairie. Menopausal specialists have known about NK drugs like Veozah for years now, she said, closely following the clinical trials where the drug was tested.

Those trials, called the SPIRIT trials, enrolled thousands of women over multiple years and found that Veozah worked to prevent hot flashes. Minor side effects accompany the drug, including headaches and gastrointestinal indications, symptoms Dr. Prairie said are fairly common even with placebos.

The contraindication to watch out for is how the drug impacts the liver. Women who have liver disease, such as cirrhosis, or kidney disease, should not take Veozah. The plan is for physicians to check patient liver enzyme levels before beginning the medication, and to continue to check levels intermittently. Veozah also interacts with certain drugs, such as the antibiotic Cipro and related medicines.

While hormone therapy works well to treat hot flashes, not everyone can take these medications — they come with risks, and women with hormone-related cancers, like estrogen receptor-positive breast cancer, cannot take hormones, including estrogen, to control hot flashes.

“I hope that [Veozah] gives us another option for patients that are really hit hard by their menopause symptoms,” said Dr. Scruggs.

“This is another alternative, another tool in the toolbox,” said Dr. Roberta Renzelli-Cain, a menopause specialist and OBGYN in Morgantown, West Virginia, and an associate professor of obstetrics and gynecology at WVU School of Medicine. “Everybody is super excited about this medication.”

In medical school, Dr. Renzelli-Cain said she was taught to tell women not to worry about hot flashes — that they would go away. But certain women, deemed “super-flashers,” struggle with hot flashes for many years, some for the rest of their lives. Super-flashers are also at a higher risk for heart disease, said Dr. Renzelli-Cain, which means they can’t take hormone therapy long-term.

“This medication has a lot of promise for [super-flashers], because they can stay on it longer,” she said.