The FDA Approved A New Menopause Drug To Treat Hot Flashes

When you think about menopause, you probably think of hot flashes. I remember when my mom was going through menopause and, suddenly red and sweating, she’d stop what she was doing to go stand under a ceiling fan — she called these her “personal summers.” Up to 80% of women experience hot flashes and night sweats during menopause, and they can last for years, according to Harvard Health. On Friday, the FDA approved a new drug — elinzanetant — to treat moderate to severe hot flashes and night sweats without the use of hormones.

Bayer announced Friday that its version of the drug, under the brand name Lynkuet, will be available in the U.S. beginning in November of this year. Lynkuet comes in the form of soft gel capsules that are taken once daily at bedtime, with or without food, the brand said in a press release. Hormone therapy is currently the most common treatment for people experiencing troublesome menopause symptoms, but elinzanetant does not rely on hormones to help patients get relief from their personal summers, said the brand.

Instead, the drug works by blocking two types of receptors in the brain that impact temperature regulation. In research trials, it successfully reduced the frequency and severity of both night sweats and hot flashes in postmenopausal women ages 40 to 65 when compared to a placebo. Most participants reported improvement in their symptoms, and their ability to sleep at night, one week after beginning treatment, according to Dr. JoAnn Pinkerton, one of the lead clinical trial investigators, in an interview with The New York Times.

There is one other medication, fezolinetant, that uses this same pathway in the brain to treat vasomotor symptoms (the medical term for issues with temperature regulation, like hot flashes), but it only blocks one of the receptors involved instead of two. Many women are also prescribed drugs intended for other uses but that have been shown to have some effect on hot flashes, including antidepressants and antiseizure medications.

It matters that non-hormonal treatment options for hot flashes exist — hormone replacement therapy is safe and effective for many people, but it’s not recommended for those who have ever had breast or endometrial cancer, stroke, heart attack, blood clots, or liver disease, according to the American College of Obstetricians and Gynecologists. An estimated 6,000 women enter menopause every day in the United States, meaning a wide swath of the population experiences symptoms like hot flashes that can impact their functioning and quality of life.

So yes, while it’s just one new pill, having a new treatment option feels like a big win for women who have been struggling with menopause and perimenopause symptoms.