What you need to know about the new treatment for hot flashes

The Food and Drug Administration on Friday approved a new nonhormonal oral medication, under the brand name Veozah, designed to treat menopausal hot flashes. The drug offers women a “safe and effective treatment option,” said Dr. Janet Maynard, director of the FDA Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine in a statement.

Hot flashes, also called vasomotor symptoms, affect about 75 percent of menopausal and perimenopausal American women. A large body of evidence suggests that this symptom, in which a woman suddenly and overwhelmingly feels hot, can have a serious impact on quality of life and productivity. Studies have shown that black women suffer from it more severe and more frequent hot flashes for longer duration.

Still, there are few safe and effective treatment options for hot flashes, said Dr. Stephanie Faubion, medical director of the North American Menopause Society and 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 carries risks for women with certain health conditions. Misconceptions about it, largely rooted in a 2002 study that has since been challenged, have put many other women off it, she said.

There has been only one other non-hormonal treatment effectively shown manage hot flashes – paroxetine, which is primarily used to treat depression but is FDA approved to also be used for menopausal symptoms.

Decades of limited treatment options created a gaping “unmet need,” making Veozah, which is produced by Japanese pharmaceutical company Astellas, both groundbreaking and highly anticipated, 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 looking forward to for a long time.”

How does the drug work?

About ten years ago, researchers identified neurons in the brain, known as KNDy neurons, that regulate body temperature, and found that those neurons were primarily driven by estrogen. When women transition to menopause and their estrogen levels drop, “these neurons go into overdrive,” said Dr. Streicher, which perceives the body as being hotter than it is, thus triggering a cascade of events to cool the body, such as sweating.

Veozah contains a compound called fezolinetant, which binds to those neurons and “calms them down,” said Dr. Streicher.

Astellas conducted three studies for Veozah at test sites in Canada, the US and countries in Europe and collectively included more than 3,000 women with moderate or severe hot flashes. Compared to a placebo, the drug is significant reduced severity and frequency of hot flashes for women taking 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 the University of Colorado School of Medicine who served as a scientific advisor to Astellas during trials of the drug, women reported feeling a difference within a week.

There are still no studies comparing the efficacy of fezolinetant to that of estrogen – which may reduce frequency of hot flashes by 75 percentsaid Dr. Faubion – but it seems to be more effective than paroxetine.

Who can use Veozah?

The trial included women ages 40 to 65, and the drug was effective in those age groups. But it may be particularly helpful for women over age 60, because starting hormonal treatments at that age can be considered risky, making it “potentially a very, very good option” for those women, said Dr. Streicher, who was not involved in the investigation. but revised his findings.

“The other nice thing about the clinical trials is that they had a good cross-section of women — Black women, Asian women, Latina women,” she said. “And it worked just as well on black women as it did on white women — that’s huge.”

What are the side effects and risks of the drug?

One of the main concerns at the start of the trial was liver toxicity. Similar versions of the drug produced by other companies found this to be a major side effect, and those studies were halted, said Dr. Santoro.

In the three studies of the drug, 25 women showed elevated liver enzymes, according to the FDAs safety statement. For this reason, women with known liver damage should avoid the drug, and the FDA recommends having blood tests 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, said Dr. Faubion, specifically any effects on “heart health, bone health, sexual health, mood symptoms, or weight.” That, she added, is difficult to fully estimate until the drug is on the market and used by more people for longer periods of time. Estrogen alone, Dr. Faubion has been shown to provide long-term health benefits other than reducing hot flashes.

How much will it cost and how soon can I get it?

The company has said the product will be available in pharmacies within three weeks and will cost $550 for a 30-day supply.

That price is prohibitive, said Dr. Faubion, and may not be covered by insurance companies. “This has to be affordable so that women can really take advantage of it,” she said.