- The FDA has approved a medication that can help treat hot flashes caused by menopause.
- The drug is called Veozah and is an alternative form of hormone therapies used for hot flashes.
- Traditionally hot flashes have been treated with menopausal hormone therapy, which is essentially estrogen.
The Food & Drug Administration (FDA) has approved a new medicine designed to offer women
“Health care providers and their patients have been long awaiting an effective alternative to hormone therapy to treat vasomotor symptoms associated with perimenopause and menopause,” said Dr. Kathryn Rutenberg, an OB/GYN at Lenox Hill Hospital in New York.
A hot flash is an intense feeling of heat not caused by external sources.
The skin may become red and the hot flash can also cause sweating. Night sweats are a version of hot flashes and they can disrupt sleep. Women begin to go through menopause between the ages of 45 and 55 and hot flashes occur in roughly
“Hot flashes last anywhere from a few seconds to a minute or two. It causes a decrease of blood flow to the brain, and is very disconcerting for women who experience them. Twenty-five to 30% of women who experience hot flashes experience severe ones, which means they are having seven, eight, or nine hot flashes a day. It’s extremely disruptive,” said Dr. Samantha Dunham, Co-Director of the Center for Midlife Health and Menopause in the Department of Obstetrics & Gynecology at NYU Langone Health.
Veozah is an oral medication designed for the treatment of moderate to severe hot flash symptoms. 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.
“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.”
Veozah is not a hormone therapy drug, which makes it ideal for women who are not able to be treated with hormones. Traditionally hot flashes have been treated with menopausal hormone therapy, which is essentially estrogen.
“Estrogen works so well for so many things, like strengthening bones, preventing fractures, and is great for the urinary symptoms of menopause,” said Dunham. “But Veozah is great for someone who cannot take estrogen, like maybe those who have a higher risk of clotting or those who have a history of estrogen-related cancers.”
“While hormone therapy does provide effective treatment for many women debilitated by vasomotor symptoms, it is generally not prescribed for someone who is at significant risk of stroke, heart attack, and blood clots,” said Rutenberg. “It is also not for women who have known or suspected estrogen/progesterone-sensitive cancers like breast and endometrial cancer.”
Veozah is an oral medication that includes one 45 milligram pill per day, taken at the same time each day. If a dose is missed, or not taken at the regular time, patients should take it as soon as possible and return to their regular schedule the following day.
The clinical trials took measures to ensure the safety of the medication. Randomized controlled clinical trials demonstrated effectiveness compared to a placebo after 12 weeks of 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,” said Rutenberg. “The biggest risk appears to be elevation of liver function tests and so it is recommended to monitor baseline and quarterly liver tests for the first year.”
Rutenberg added that this medication is not for those with liver damage, like cirrhosis, or those with end stage renal disease. The most common side effects of Veozah include abdominal pain, diarrhea, insomnia, back pain, hot flush, and elevated hepatic transaminases, which affects the liver.
“Traditionally hormone replacement therapy used for hot flashes but the risks were worrisome to patients and doctors,” added Dr. Jennifer Wu, an OB/GYN at Lenox Hill Hospital. “Veozah is not a hormone and will be a welcome addition to the treatment regimen for menopause.”
“It has a really nice safety profile,” added Dunham. “And it’s been approved to take up to a year. Hot flashes can last anywhere from seven to 10 years so I think it’s a great beginning to see how it does in the first year of use.”