A new option for treating hot flashes during menopause
The Food and Drug Administration has approved a new nonhormonal oral drug, under the brand name Veozah, designed to treat menopausal hot flashes. The drug provides women with a “safe and effective treatment option,” Dr. Janet Maynard, director of the FDA Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine, said in a statement.
Hot flashes, also called vasomotor symptoms, affect roughly 75% of menopausal and perimenopausal American women. A large body of evidence suggests that this symptom, in which a woman feels suddenly and overwhelmingly hot, can have a serious impact on quality of life and productivity. Studies have found that Black women suffer from more severe and frequent hot flashes for longer durations.
Yet there have been few safe and effective treatment options for hot flashes, said Dr. Stephanie Faubion, medical director for the North American Menopause Society and a director of the Mayo Clinic Center for Women’s Health. Hormone therapy is the most effective treatment for women under age 60, but it presents risks for women with certain health conditions. Misconceptions about it, which are largely rooted in a study from 2002 that has since been challenged, steered many other women away from it, she said.
There is only one other nonhormonal treatment that has been shown to effectively manage hot flashes. It is paroxetine, which is primarily used to treat depression but was approved by the FDA to be used for menopause symptoms too.
Decades of limited treatment options created a gaping “unmet need,” making Veozah, which is produced by the Japanese pharmaceutical company Astellas, both groundbreaking and long overdue, said Dr. Lauren Streicher, a clinical professor of obstetrics and gynecology at Northwestern University and medical director of the Northwestern Medicine Center for Menopause.
“When you think about the impact of vasomotor symptoms on work, on cognitive function, on sleep, on quality of life — the availability of another option is exciting,” she said. “This is something we’ve been anticipating for a long time.”
About a decade ago, researchers identified neurons in the brain, known as KNDY neurons, that regulate body temperature, and found that those neurons were primarily controlled by estrogen. When women transition to menopause and their estrogen levels fall, “these neurons go into overdrive,” Streicher said, perceiving the body to be hotter than it is and thus setting off a cascade of events to cool the body down, like sweating.
Veozah contains a compound called fezolinetant, which binds to those neurons and “calms them down,” Streicher said.
Astellas conducted three trials for Veozah at test sites in Canada, the U.S. and countries in Europe and collectively involved over 3,000 women who had moderate or severe hot flashes. Compared with a placebo, the drug significantly reduced the severity and frequency of hot flashes for women who took one pill a day.
Many women taking the drug reported a difference by week four.