This New Menopause Drug Can Treat Hot Flashes With Minimal Side Effects

• The FDA approved Veozah, a non-hormonal medication that can help reduce the frequency and intensity of hot flashes.

• Veozah is the first drug to target neurokinin B, a brain chemical that helps to regulate body temperature.

• This drug approval is especially important for breast cancer patients and other people who cannot take hormone replacement therapy, experts say.

For millions of menopausal women, hot flashes can cause sleepless nights, disrupt the workday, and can even increase the risk of heart disease and other conditions. Hormone replacement therapy (HRT) is the standard treatment for easing menopause symptoms, but not everyone can or wants to take hormones.

Now, a new non-hormonal treatment is coming to the market. The Food and Drug Administration (FDA) last week approved a new drug that can reduce the intensity and frequency of vasomotor symptoms caused by menopause, which include hot flashes and night sweats.

The drug, called Veozah (fezolinetant), is the first to target a chemical in the brain that regulates body temperature.

Existing non-hormonal treatment options include anti-anxiety and anti-depression medications, which might have disruptive side effects. The new daily oral pill comes with few side effects and can be safely used by breast cancer survivors and others who cannot take hormone therapies, according to its drugmaker Astellas.

About 80% of U.S. women experience hot flashes during the menopausal transition, and the symptoms can last for a decade after their last menstrual period.

“Whether mild, moderate or severe, [hot flashes] are very disruptive for women's lives," said Samantha Dunham, MD, co-director of the Center for Midlife Health and Menopause at New York University Langone Health. "It’s not just a matter of being uncomfortable—it interrupts sleep, it ends up really affecting mood. It spills into every aspect of a person's life. It's wonderful to have this medication as another option."

How Effective Is Veozah?

Body temperature is regulated by the hypothalamus, the thermostat of the brain. It relies on the balance between the hormone estrogen and a chemical in the brain called neurokinin B (NK-B). But during the menopausal transition, declining estrogen levels can disrupt this equilibrium.

When this happens, neurons in the brain send the signal that the body is hot, even when it’s not. The resulting feelings of sudden warmth and sweating in the face, neck, and chest are often called “hot flashes” or “hot flushes.”

Fezolinetant, the active ingredient in Veozah, works by blocking NKB in the temperature control portion of the brain to restore balance, according to Risa Kagan, MD, FACOG, a clinical professor of obstetrics and gynecology at the University of California San Francisco and a consultant to Astellas. It’s “extremely exciting,” she said, to have an option that works for people who can’t take hormone therapies.

Astellas tested the drug in three phase 3 clinical trials involving more than 3,000 people in the United States, Canada, and Europe. One of those trials tested safety over a year, while the other two studied how well the drug worked over 12 weeks.

In the clinical trials, the patients who took a 45-milligram tablet of Veozah daily saw a reduction of vasomotor symptoms by 57% compared to 30% in the placebo group. The participants had an average of about 12 vasomotor symptoms each day before taking Veozah, and down to about six after one month of treatment. They also slept better throughout the 40 weeks of testing.

“Many women want to know how long it will take to get some benefit. The good part here is that we can get tell them that within a week, you're going to get something. By four weeks it’s going to be better. And by 12 weeks it’s really significant,” Kagan told Verywell.

Veozah appears to be nearly as effective as estrogen therapy in certain groups, said Lauren Streicher, MD, a clinical professor of obstetrics and gynecology at Northwestern University’s Feinberg School of Medicine and a certified menopause practitioner.

Streicher, who is not affiliated with the studies or Astellas, said Veozah appears to work best in patients who are a year or more out from their last menstrual period.

Patients should aim to take the medication at the same time each day and take a missed dose as possible unless there are less than 12 hours until the next scheduled one, Marci English, Vice President and Head of BioPharma Development at Astellas, told Verywell in an email.

How Safe Is Veozah?

Researchers conducted a year-long phase 3 trial to assess the safety of Veozah. They found that participants taking a placebo and Veozah had almost the same rate of adverse events related to the treatment.

Due to a small risk of liver damage, the FDA said providers should conduct a blood test before prescribing the drug, and then every three months for the first nine months of treatment. These recommendations are likely a case of the FDA doing its due diligence, Streicher said.

“I think people can feel pretty good about this one,” she added.

Compared with hormone therapy, which Streicher recommends taking for one's entire post-menopausal life, patients can Veozah for as long as they want to treat their hot flashes. Streicher said it may make sense for patients to take a vacation from the medication every couple of years to see if they're still flashing.

Astellas doesn’t yet have any data on the effects of starting and stopping the treatment, English said.

Providers sometimes prescribe anti-anxiety, anti-depression, and nerve pain medications for treating hot flashes. However, these medications often come with side effects, such as weight gain and blunted sex drive, making them unappealing to some patients.

Veozah, on the other hand, comes with mostly minor side effects, like headaches.

The list price is $550 for a 30-day supply, but the true cost to patients will be lower after discounts and insurance coverage, according to English.

How Does Veozah Compare to Hormone Therapy?

Hormone therapy replaces the estrogen, and sometimes progesterone, that a person loses while undergoing menopause. It can help with hot flashes, vaginal dryness, prevention of osteoporosis, and other symptoms of outcomes of menopause.

While hormone therapies have been FDA-approved since 2002, some patients and providers are wary of taking estrogen, largely due to stigma resulting from long-debunked claims that hormone therapy can increase breast cancer risk.

“The problem we have is that in spite of the fact that estrogen is safe and effective, a very, very small number of women actually use estrogen therapy, mostly because of misconceptions about the safety,” Streicher said.

Compared to the one year of data Astella has collected on Veozah, researchers have multi-year studies on hormone therapy indicating its benefits for cardiovascular, bone, and cognitive health, in addition to reducing vasomotor symptoms. Streicher said it’s possible that Veozah offers similar benefits, but it’s too soon to know. In the meantime, she said, estrogen therapies remain the gold standard.

The Veozah approval, Kagan said, is the product of years of research and an important step toward caring for a large swatch of patients who have long lived without adequate treatment options.

“It's amazing to me to watch over my career of 40 years and being so involved with menopausal women both in clinical research as well as teaching, how many people basically ignore hot flashes and think that they're just nuisances that will go away or get better with time. Women should not have to suffer in silence," Kagan said.

If you're experiencing hot flashes, night sweats, and other menopause symptoms, talk with your provider about your treatment options. You can consult the North American Menopause Society's list of certified menopause practitioners to find an expert well-versed in both hormonal and non-hormonal options.