Experiencing hot flashes and night sweats due to menopause? FDA approves new hormone-free drug

If you're in your tardily 40s and 50s, you may be familiar spirit with experiencing a sudden hie of hot up in your upper personify. Or even waking up soaked in sweat. These are widely known as hot flashes and night sweats, common symptoms of perimenopause or menopause - a phase in which a women's reproductive cycle starts coming to an end. The transition is difficult, especially with the stigma around it and hormone replacement therapy (HRT). While women are mostly talk about their struggles in hushed tones, health organisations are increasingly looking at ways to help women manage menopause better. In a latest move, the US Food and Drug Administration (FDA) has approved Lynkuet, a new daily pill from Bayer, offering a hormone-free option to help reduce hot flashes.

Lynkuet, also known as elinzanetant, is designed to help control body temperature. It is the second medication to address hot flashes by targeting the neurokinin-3 receptor in the brain. These receptors play a key role in regulating body temperature and sleep.

When women go through menopause, levels of estrogen - one of the two key sex hormones in women - drop. This can lead to hot flashes. Lynkuet helps by blocking specific receptors in the brain, which calms the pathways that cause hot flashes and related sleep problems. This drug went through three clinical trials with over 2,000 women who had moderate to severe hot flashes. The results, published in JAMA and JAMA Internal Medicine, showed that women taking Lynkuet had about 55% fewer hot flashes after just 12 weeks compared to those taking a placebo. Many participants started to feel relief within a couple of weeks.

“It’s important that women know they have choices for treating moderate to severe hot flashes due to menopause. This approval further expands a woman’s options for treating these symptoms,” Claire Gill, President and Founder of the National Menopause Foundation, said in a Bayer press statement.

Lynkuet may help women with hormone receptor-positive breast cancer and who experience hot flashes from their hormone-blocking treatments. In a study published in The New England Journal of Medicine, women who took Lynkuet, reported fewer hot flashes per day than those who took a placebo.

They also experienced better sleep and an overall improved quality of life. This is very important because traditional hormone therapy isn’t an option for women battling breast cancer. With Lynkuet, they will have a safer alternative to manage those difficult symptoms without using hormones.

The news about a hormone-free drug may be encouraging, it's important to be careful with any new medication and understand its safety and side effects. The trials found that some common side effects were mild fatigue, headaches, and drowsiness. Bayer also reported that some participants had higher liver enzyme levels, suggesting liver issues. Because of this, the FDA advises checking liver function before starting the medication and again after three months of treatment.

No serious liver injuries were found in studies of Lynkuet that lasted up to a year, but monitoring is still ongoing. Pregnant women or those who might get pregnant should avoid Lynkuet because animal studies suggest it could cause pregnancy problems.

Hot flashes affect about 80% of women during menopause, and these symptoms can last for years, according to the Journal of Midlife Health. “They can interfere with sleep and focus, making daily life challenging," Dr Pooja C Thukral, Consultant – Obstetrician and Gynaecologist, Cloudnine Group of Hospitals, once told Health Shots. Some non-hormonal treatments, like certain antidepressants and gabapentin, may help, but they are often not as effective.

Lynkuet has been approved, which means there are now more options for treating hot flashes.

“This treatment focuses on the biological reasons behind hot flashes instead of just using hormonal therapies," Dr Jayashree Nagaraj Bhasgi, Senior Consultant, Obstetrics and Gynaecology, Fortis Hospital, tells Health Shots. For those who cannot take hormones or prefer not to, this provides a new opportunity for relief.

The new drug will be available in US pharmacies starting in November 2025, but you will need a prescription from your doctor. Bayer expects the monthly price to be around $625, according to The New York Times.

(Note to readers: This article is for informational purposes only and not a substitute for professional medical advice. Always seek the advice of your doctor with any questions about a medical condition.)

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