Drugmaker Bayer announced that the Food and Drug Administration has approved a first-of-its-kind drug to treat moderate to severe hot flashes due to menopause.
Lynkuet is a once-daily soft gel capsule that studies show can reduce the frequency and severity of hot flashes. The drug works by blocking both NK1 and NK3 receptors on KNDy neurons, calming the overactive temperature signals that trigger moderate to severe hot flashes.
The drug has already received regulatory approval in Australia, Canada, the United Kingdom and Switzerland, and is pending approval in the European Union.
Bayer expects Lynkuet to be available in the United States next month.
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“The FDA approval of Lynkuet is an important new option for women and providers who are treating moderate to severe hot flashes due to menopause,” said Dr. Yesmean Wahdan, head of medical affairs USA & North America at Bayer. “As a global leader in women’s healthcare with more than 100 years of research and experience, we are proud to bring this new treatment option to market for women who are going through menopause and seeking hot flash relief.”
According to UCLA Health, 75% of women experience hot flashes during menopause, but only half seek treatment. The average age for the menopause transition is 51, though it can range from age 40 into the early 60s. Hot flashes can persist for seven to 10 years after menopause begins.
Current treatments include hormone therapy, antidepressants and other medications.