The Food and Drug Administration approved a new nonhormonal oral drug Friday, under the brand name Veozah, designed to treat menopausal hot flashes. The drug provides women with a “safe and effective treatment option,” Dr. Janet Maynard, director of the F.D.A. Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine said in a statement.
Hot flashes, also called vasomotor symptoms, affect roughly 75 percent of menopausal and perimenopausal American women. A large body of evidence suggests that this symptom, in which a woman feels suddenly and overwhelmingly hot, can have a serious impact on quality of life and productivity. Studies have found that Black women suffer from more severe and frequent hot flashes for longer durations.
Yet there have been few safe and effective treatment options for hot flashes, said Dr. Stephanie Faubion, medical director for the North American Menopause Society and a director of the Mayo Clinic Center for Women’s Health. Hormone therapy is the most effective treatment for women under the age of 60 but it presents risks for women with certain health conditions. Misconceptions about it, which are largely rooted in a study from 2002 that has since been challenged, steered many other women away from it, she said.
There is only one other nonhormonal treatment that has been shown to effectively manage hot flashes — paroxetine, which is primarily used to treat depression but was approved by the F.D.A. to be used for menopause symptoms too.
Decades of limited treatment options created a gaping “unmet need,” making Veozah, which is produced by the Japanese pharmaceutical company Astellas, both groundbreaking and long overdue, said Dr. Lauren Streicher, a clinical professor of obstetrics and gynecology at Northwestern University and medical director of the Northwestern Medicine Center for Menopause.
“When you think about the impact of vasomotor symptoms on work, on cognitive function, on sleep, on quality of life — the availability of another option is exciting,” she said. “This is something we’ve been anticipating for a long time.”
How does the drug work?
About a decade ago, researchers identified neurons in the brain, known as KNDy neurons, that regulate body temperature, and found that those neurons were primarily controlled by estrogen. When women transition to menopause and their estrogen levels fall, “these neurons go into overdrive,” Dr. Streicher said, perceiving the body to be hotter than it is and thus setting off a cascade of events to cool the body down, like sweating.
Veozah contains a compound called fezolinetant, which binds to those neurons and “calms them down,” Dr. Streicher said.
Astellas conducted three trials for Veozah at test sites in Canada, the U.S. and countries in Europe and collectively involved over 3,000 women who had moderate or severe hot flashes. Compared to a placebo, the drug significantly reduced the severity and frequency of hot flashes for women who took one pill a day.
Many women taking the drug reported a difference by week four. In some cases, said Dr. Nanette Santoro, a professor of obstetrics and gynecology at University of Colorado School of Medicine, who was a scientific adviser for Astellas during trials of the drug, women reported feeling a difference in a week.
There are still no studies comparing the efficacy of fezolinetant to that of estrogen — which can reduce frequency of hot flashes by 75 percent, Dr. Faubion said — but it seems to be more effective than paroxetine.
Who can use Veozah?
The trial included women aged 40 to 65 and the drug was effective across those age groups. But it might be particularly helpful for women over 60 because at that age, starting hormonal treatments can be considered risky, making it “potentially a very, very good option” for those women, said Dr. Streicher, who was not involved with the study but reviewed its findings.
“The other thing that’s nice about the clinical trials is they had a good cross-section of women — Black women, Asian women, Latina women,” she said. “And it worked just as well in Black women as in white women — that’s huge.”
What are the side effects and risks associated with the drug?
One of the main concerns going into the trial was liver toxicity. Similar versions of the drug produced by other companies found that to be a major side effect and those trials were discontinued, Dr. Santoro said.
Across the drug’s three trials, 25 women showed elevated liver enzymes, according to the F.D.A.’s safety statement. For this reason, women with known liver damage should avoid the drug and the F.D.A. recommends doing blood work before starting the medication to screen for liver damage. It is also not safe for patients with known kidney failure or kidney disease.
There are “still a lot of unknowns” about the drug, Dr. Faubion said, particularly any effects on “heart health, bone health, sexual health, mood symptoms or weight.” That, she added, is difficult to gauge fully until the drug is on the market and used by more people for longer durations. Only estrogen, Dr. Faubion noted, has been shown to provide other long-term health benefits beyond mitigating hot flashes.
How much will it cost and how soon can I get it?
The company has said that the product will be available in pharmacies within three weeks and will cost $550 for a 30-day supply.
That price is prohibitively expensive, Dr. Faubion said, and may not be covered by insurance companies. “This needs to be affordable so women can really utilize it,” she said.
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