FDA approves new menopause drug to treat hot flashes

For the first time, the FDA has approved a new, non-hormonal drug used to treat hot flashes in menopause. 

If you haven’t yet experienced hot flashes as a result of perimenopause or menopause, you likely know what they are—or know someone close to you who has suffered from them. Hot flashes and night sweats, also known as vasomotor symptoms (VMS), are a hot, flushed, sweaty feeling that stems from the upper body, and are the most commonly reported symptom for which women seek treatment during menopause, impacting an estimated 21 million U.S. women by 2025. 

Hot flashes impact quality of life

Hot flashes can range from mild to severe, and some women experience symptoms for more than 10 years after their final menstrual period. It goes without saying that hot flashes can be disruptive to daily activities, and because they also go hand in hand with night sweats and insomnia, they can have broader impacts on energy levels, cognition and even work success.

Recent research from Mayo Clinic found that menopause symptoms directly affect women at work: “A full 13% of the women we surveyed experienced an adverse work outcome related to menopause symptoms, and about 11% were missing days of work because of these symptoms,” lead study author Dr. Stephanie Faubion, director of Mayo Clinic Women’s Health in Rochester, Minn., said in a news release.

Related: How employers can recognize menopause in the workplace

But relief from hot flashes may be within reach. Drug maker Astellas has received FDA approval for Veozah (fezolinetant), a new drug that targets a neuron receptor in the brain that becomes unbalanced with decreasing estrogen levels, helping to better regulate body temperature, thereby reducing hot flashes.

Until now, previous medications for hot flashes consisted of hormonal therapies, which can come with significant side effects, like blood clots and stroke (though the risk is higher for women over 60), and aren’t a good option for all.  

“Hot flashes as a result of menopause can be a serious physical burden on women and impact their quality of life,” said Janet Maynard, M.D., M.H.S., director of the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine, in the FDA press release. “The introduction of a new molecule to treat moderate to severe menopausal hot flashes will provide an additional safe and effective treatment option for women.”

Related: Fatigue, hot flashes, insomnia—could it be perimenopause?

A new, non-hormonal drug for hot flashes

The 45 milligram pill should be taken once a day, with or without food, around the same time each day. Two 12-week, randomized, double-blind clinical trials found that in study participants (the average age was 54), Veozah reduced moderate to severe hot flashes by more than 50%. 

Of course, no medication is without side effects, and Veozah was found to increase liver enzymes in some trial participants. Before using Veozah, patients should have bloodwork done to test their liver enzymes, and routine bloodwork should be repeated every three months for the first nine months of using the medication to check for liver health. The other most common side effects of Veozah were abdominal pain, diarrhea, insomnia, back pain and hot flush. 

Related: Yep, you can get pregnant during perimenopause

The medication is also costly. A 30-day supply of Veozah runs upwards of $550—before rebates. That’s $6,600 per year, though the Institute for Clinical and Economic Review has advised a lower price of $2,000 to $2,600 per year. Astellas said that they expect the drug to be available in pharmacies within the next three weeks, and that they expect insurance coverage to increase over the course of the year.