FDA approves novel drug for hot flashes

This medication can treat a symptom that affects roughly 80% of menopausal women in the U.S.

By Jennifer Larson | May 18, 2023 Medically reviewed by Karen Berger, Pharm.D.

The U.S. Food and Drug Administration (FDA) recently approved the oral medication Veozah (fezolinetant) for the treatment of moderate to severe hot flashes caused by menopause. Manufactured by Astellas Pharma, Veozah is the first neurokinin 3 (NK3) receptor antagonist to receive approval for the treatment of vasomotor symptoms (hot flashes).

Hot flashes are very common among people going through menopause. According to the FDA, about 80% of menopausal women experience vasomotor symptoms like hot flashes. And when they’re frequent and severe, hot flashes and night sweats can take a serious toll on a person’s quality of life—which is why the approval of Veozah is important.

How Veozah works

Currently, hormone therapy is considered the most effective treatment available for this type of symptom, says Stephanie S. Faubion, MD, medical director for The North American Menopause Society. But hormone therapy isn’t for everyone. Some people have a history of heart attack, stroke, blood clots, or breast cancer, among other health conditions, that might preclude them from using this treatment. For these individuals, Veozah may be a safer—and still effective—treatment option.

Veozah works by targeting the neural activity that causes hot flashes. Specifically, it works by “binding to and blocking the activities of the NK3 receptor, which plays a role in the brain’s regulation of body temperature,” according to the FDA. The NK3 receptors are found in the central nervous system and can trigger hot flashes.

The effectiveness of Veozah in addressing hot flashes was demonstrated in two phase 3 clinical trials that each ran for a total of 52 weeks.

As yet, there have been no studies comparing Veozah to hormone therapy. “It does appear to be safe and effective and a great non-hormonal option,” Dr. Faubion says.

Who can take Veozah?

Veozah comes with a warning for elevated liver enzymes (liver injury) from the FDA, which may disqualify some people from taking it. People who have cirrhosis or severe or end-stage renal disease should not take Veozah.

Patients will need to undergo blood work to test for liver damage before they can begin taking this medication. Additionally, people who take Veozah will need to undergo routine blood work every three months for the first nine months.

“The benefits outweigh the risks for the majority of healthy women who are under the age of 60 and within 10 years of menopause onset who need symptom relief,” Dr. Faubion says. “It is wonderful to see a new treatment option for hot flashes and night sweats on the market. That women have more options is a good thing.”