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The FDA Just Approved a New Drug for Menopause — Here’s What You Need to Know

Menopause just got a bit more bearable. Last Friday, the FDA approved a nonhormonal drug called Veozah (fezolinetant) to treat moderate to severe vasomotor symptoms such as hot flashes and night sweats caused by menopause. 

“Hot flashes are often dismissed in medicine as a ‘quality of life’ issue that women are just expected to endure,” says neuroscientist Dr. Lisa Mosconi in a recent Instagram post. “In reality, hot flashes are actual neurological symptoms that can significantly disrupt the daily lives of over 75% of all women going through menopause.”

Hot flashes happen because there is an imbalance between estrogen levels and a brain chemical called neurokinin B. Before menopause, this balance helped in regulating a person’s body temperature. But with less estrogen in the body, the balance shifts, resulting in periods of sweating, flushing, and chills.

Veozah works to restore balance. As a neurokinin (NK3) receptor antagonist, Veozah blocks the chemical in the brain from binding to its receptor. This, in turn, lowers the number and intensity of hot flashes.

“Hot flashes as a result of menopause can be a serious physical burden on women and impact their quality of life,” says Janet Maynard, an MD with the FDA’s Center for Drug Evaluation and Research, in a news release. “The introduction of a new molecule to treat moderate to severe menopausal hot flashes will provide an additional safe and effective treatment option for women.”

Veozah was proven highly safe and effective in two year-long phase 3 clinical trials involving over 3,000 women with moderate to severe menopausal hot flashes. Women were randomly assigned to take the drug or a placebo for three months. The 12-week period showed women taking Veozah had a significant reduction in the number of hot flashes they had each week than women taking a placebo. Afterward, the scientists tracked the health of both groups of women for another 40 weeks to study the long-term safety of using the medication.

If you experience menopause-related hot flashes and night sweats, keep reading to learn more about Veozah and determine if the drug is right for you.

Who Is Veozah For?

Hormone replacement therapy is a common treatment for dealing with menopausal hot flashes, but it’s not a right fit for everyone. Women with a history of vaginal bleeding, stroke, heart attack, blood clots, or liver disease are strongly discouraged from hormone therapy because it increases their risk for blood clots, stroke, and cancer. Since Veozah is not a hormone, most women who fall under this category now have a treatment option for relief from disruptive hot flashes.

How Is Veozah Taken?

The 45-milligram pill is taken once daily by mouth and should be taken at the same time each day. If you miss a day or do not take it at your usual time, take it as soon as possible and resume your regular schedule the next day.

What Are the Risks & Side Effects of Veozah?

One concern with taking Veozah is the risk of liver injury. The FDA advises people interested in taking Veozah to get blood work done first to make sure there is not any prior liver infection or damage. People should continue getting bloodwork every three months for the first nine months when using the medication. If you’re experiencing nausea, vomiting, or yellowing of the skin and eyes—all signs of liver damage—contact your doctor immediately. People with cirrhosis, kidney injury, or kidney disease are advised against taking Veozah.

The most common side effects from using Veozah include abdominal pain, diarrhea, insomnia, back pain, hot flush, and elevated liver enzymes, which could suggest liver damage.

When Will Veozah Be Available?

According to the pharmaceutical company Astellas, Veozah could be available in pharmacies in as soon as three weeks.

How Much Does Veozah Cost?

Unless covered by insurance, the drug comes at a steep price tag of $550 a month.

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