FDA approves new medication to treat menopause symptoms

The Food & Drug Administration (FDA) has approved a once-a-day pill for dealing with hot flashes brought on by menopause.

The new drug, Veozah (fezolinetant), is an oral medication that can be used as an alternative to the hormone therapies that are traditionally used to treat hot flash symptoms. 

What are hot flashes?

Hot flashes are an intense feeling of heat not caused by an external source and cause a decrease of blood flow to the brain, according to Dr. Samantha Dunham, co-director of the Center of Midlife Health and Menopause in the Department of Obstetrics & Gynecology at NYU Langone Health.

Menopause occurs in roughly 80% of menopausal women. Women begin to go through menopause between the ages of 45 and 55.

How does Veozah work?

Veozah blocks the chemical in the brain called neurokinin B (NKB), which regulates body temperature. 

“This drug works through a specific mechanism of action that is new. It is a novel class of drug and it is a brand-new mechanism of action that has been researched and understood,” said Dunham. “It helps to make the thermostat in the brain go back to normal. During hot flashes, the [proverbial] thermostat becomes unregulated. Veozah resets that thermostat and drops the number of hot flashes significantly.”

What’s the difference between Veozah and hormone therapy?

Veozah is not a hormone therapy drug. Traditional treatment includes boosting the hormones estrogen and progestin to reduce menopause symptoms like sweating, flushing, and chills

However, hormonal therapy isn’t the best option which makes Veozah a good option for those who cannot take estrogen. 

Hormone therapy is generally not prescribed for women who have known or suspected estrogen/progesterone-sensitive cancers like breast or endometrial cancer, as well as a history of stroke, blood clots, heart attack, and other health conditions. 

Is Veozah safe?

The clinical trials took measures to ensure the safety of the medication. According to Healthline, randomized controlled clinical trials demonstrated effectiveness compared to a placebo after 12 wells of a once-daily therapy with Veozah. Studies were then extended a year to verify safety.

“The results are very promising, both in terms of efficacy and safety,” Dr. Kathryn Rutenberg, an OB/GYN at Lenox Hill Hospital in New York, said. The most common side effects of Veozah include abdominal pain, diarrhea, insomnia, back pain, hot flush, and elevated hepatic transaminases, which affect the liver. 

“It’s recommended to monitor the baseline and quarterly liver tests for the first year,” Rutenberg said.

When will Veozah be available, and how much will it cost?

Astellas Pharma told ABC News that the drug should be available in pharmacies within three weeks.

“Prescription drug insurance plans will make their own coverage decisions, and we expect insurance coverage to increase over the course of the year,” a spokesperson for the company said Friday. “We expect VEOZAH to achieve widespread coverage over time. All copays vary by insurance plan and benefit design; however, the average commercial copays in 2022 were $37 for the preferred brand tier and $67 for the non-preferred brand tier.” To read the FDA news release on Veozah, click here


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