Is a new non-hormonal pill the answer to hot flashes in menopausal women? – Firstpost

It is not easy being a woman. After bearing menstruation and its symptoms for about three decades or so, perimenopause strikes.

Perimenopause, which can begin eight to 10 years before menopause, is marked by irregular periods, hot flashes and mood swings. Three in four people report experiencing hot flashes during the years leading up to menopause, which is when the ovaries stop producing reproductive hormones.

Now, a non-hormonal pill has been approved by the United States Food and Drug Administration (FDA) to ease hot flashes in menopausal women. But how effective is it?

We take a look.

What are hot flashes?

A hot flash is the sudden feeling of severe heat, sweating and flushed skin. The warmth usually affects the face, neck and chest.

Some people could feel cold after a hot flash due to loss of body heat.

Night sweats are hot flashes that occur during the night. Also known as nighttime hot flashes, they can disrupt sleep and cause long-term sleep loss, as per Mayo Clinic.

Hot flashes are common vasomotor symptoms (VMS), with experts attributing them to hormonal changes.

During a hot flash, a person may experience a faster heartbeat and anxiety. Each episode lasts from one to five minutes.

According to the Cleveland Clinic, up to one in three people experience more than 10 hot flashes per day. Nearly 80 per cent of all women going through menopause experience them.

These symptoms can be long-lasting, with some women experiencing them for a decade or more.

For many women, hormone therapy — estrogen, often combined with progesterone — is a safe and effective treatment for hot flashes.

However, some women, including those at high risk for certain types of breast and ovarian cancer, are advised against using hormone replacement therapies (HRTs).

“To have nonhormonal options for them is tremendously important,” Dr JoAnn Manson, an endocrinologist and professor at Harvard Medical School, told New York Times (NYT). 

“Usually in extreme cases, hormone replacement therapy is recommended but every woman does not qualify for it. HRT is safe only in a certain set of women. We do not recommend these to those with underlying health conditions or histories, including certain cancers, those with a history of or at risk of blood clotting, those with a history of stroke or heart attack, those who experience heavy bleeding and those over 60 or who are more than 10 years past their last menstrual period, as risks of cardiovascular issues and stroke may then outweigh the benefits. Avoid HRT if you have liver or gallbladder disease,” Dr Preeti Rastogi, Director & HOD, Obstetrics & Gynaecology, at Medanta, Gurugram, said to Indian Express. 

A non-hormonal pill could help such women treat hot flashes.

A non-hormonal pill for hot flashes

The US FDA has approved a non-hormonal pill, developed by German drugmaker Bayer, that could ease menopausal hot flashes and night sweats.

The drug, Lynkuet, contains the compound elinzanetant. It will treat moderate-to-severe vasomotor symptoms, commonly known as hot flashes and night sweats.

“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,” Dr Yesmean Wahdan, Bayer’s head of medical affairs in the US and North America, said in a statement.

The capsule, which has to be taken daily at bedtime, can be available in the US from November, Bayer said.

The drug is already approved in Australia, Canada, Britain and Switzerland.

In 2023, the US FDA had approved the menopause drug fezolinetant, another non-hormonal oral treatment sold under the brand name Veozah by Japanese drugmaker Astellas.

It works as an alternative to hormone replacement therapies for managing hot flashes.

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How effective is Lynkuet?

Bayer’s pill works by blocking brain chemicals responsible for hot flashes and night sweats.

A Phase 3 clinical trial of elinzanetant studied 628 postmenopausal women between the ages of 40 to 65 with troublesome hot flashes. Women taking the pill reported improvement one week after starting the treatment, researchers said in JAMA Internal Medicine.

Postmenopausal women who took the medication for 12 weeks experienced a drop of more than 73 per cent in the frequency of their vasomotor symptoms, compared with a 47 per cent reduction reported by patients receiving the placebo.

Patients taking elinzanetant also witnessed less sleep disturbance.

At 26 weeks, more than 80 per cent of women who received the drug reported at least a 50 per cent dip in the frequency of hot flashes.

“This yearlong study not only confirmed the initial findings of rapid and significant reduction in the frequency and severity of hot flashes and night sweats but also provided evidence that these effects were sustained over a year, offering hope for longer-term relief,” researcher Dr JoAnn Pinkerton, UVA Health’s director of midlife health and emeritus executive director of the North American Menopause Society, said in a statement last month when the findings were published.

“For those dealing with moderate to severe VMS due to menopause, the treatment options have been limited, especially for those who cannot or choose not to undergo hormone therapy,” Pinkerton said. “The disruptive nature of these bothersome hot flashes, particularly when they are more severe, can significantly affect women’s daily lives, both at work and at home, underscoring the urgent need for effective non-hormonal treatments.”

In India, these non-hormonal pills approved by the FDA are not yet available. In such a case, doctors recommend treating symptoms and customising medication on a case-specific basis.

“While hot flashes are the most observed symptom, women also complain of short, patchy sleep, a dry and itchy vagina and weak bones. So we have to give sleep-inducing drugs, mood relaxants, vitamin D and calcium supplements as well. Let me say that all these have to be backed up with changes in diet, lifestyle and exercise,” Dr Mannan Gupta, Chairman & HOD, Obstetrics and Gynaecology, Elantis Healthcare, Delhi, told Indian Express. 

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Are there risks linked to Lynkuet?

Nearly 30 per cent of women who got elinzanetant reported adverse effects, such as headaches and sleepiness.

Patients may also experience fatigue and joint pain. Some showed elevated liver enzyme levels, but Dr Pinkerton assured there were no concerning signs of liver toxicity, reported NYT.

Elinzanetant would not be prescribed for patients with known liver issues.

With inputs from agencies