Health and Me

Ishita Roy

F.D.A. Approves New Non-hormonal Menopause Drug To Reduce Hot Flashes

fda approves nonhormonal menopause drugs

Menopause is often seen as the end of womanhood by many women, however, as Dr Archana Nirula, a gynaecologist &amp; obstetrician, who specializes on women’s health, says, "menopause is not the end of woman's life". Thanks to the new drug <span>Lynkuet</span>, finally approved by the US Food and Drug Administration, women can now actually believe so. 

This is a nonhormonal medication, designed to treat hot flashes and night sweats in menopausal and perimenopausal women. The drug is developed by Bayer, and its main compound is elinzanetant. This is a novel therapy that could also help improve sleep disturbances commonly linked to menopause. 

<h2>Why Is This Medicine A Breakthrough?</h2>

While most medicines treating menstrual-relating symptoms for women are heavy doses of hormones, leading to many side effects, Lynkuet stands out. It offers relief without using hormones, a much-needed alternative for women who cannot or prefer not to take hormone therapy. 

<h2>What's Wrong With Hormonal Drugs?</h2>

while hormone replacement therapy (HRT), usually estrogen and progesterone, remain effective for many, it is not suitable for everyone. Women with a history or high risk of breast and ovarian cancer, or those wary of hormone-related side effects, often seek for better, safer and nonhormonal options. 

Until recently, those options were extremely limited. The first nonhormonal drug, Veozah (fezolinetant), was approved in 2023, targeting only one type of brain receptor linked to temperature regulation. Before that, doctors mostly relied on low-dose antidepressants like paroxetine to manage hot flashes, an off-label approach with limited benefits.

What makes this medicine different is the way it works on the brain. The drug is responsible for blocking two types of neurokinin receptors, namely: NK1 and NK3. These neurokinin receptors play a key role in regulating body temperature, mood, and sleep. By doing so, elinzanetant helps restore balance in the hypothalamus, which is brain's temperature control center. This usually becomes disrupted when estrogen levels fall during menopause. 

This dual-action mechanism is what sets Lynkuet apart. Unlike Veozah, which targets only one receptor, elinzanetant’s two-receptor approach could mean broader benefits, not just reducing hot flashes and night sweats, but also improving sleep quality, which many women struggle with during perimenopause and menopause.

<h2>How Did It Pass The Clinical Trials?</h2>

Clinical trials for Lynkuet involved women aged 40 to 65 who experienced frequent and severe hot flashes. According to researchers, symptom relief began as early as one week after starting treatment.

By week 12, over 70% of women taking elinzanetant reported at least a 50% reduction in the frequency of hot flashes, compared to just over 40% in the placebo group. Sleep quality also improved significantly, with many participants reporting fewer disturbances at night.

At 26 weeks, the benefits persisted, more than 80% of participants maintained a 50% reduction in symptom frequency. Those who initially received the placebo and later switched to the drug showed similar improvements, underscoring its consistent efficacy.

The most common side effects reported are mild headache, fatigue, and joint pain. A few participants also reported elevated liver enzyme levels, however there was no serious toxicity observed.

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Menopause is often seen as the end of womanhood by many women, however, as Dr Archana Nirula, a gynaecologist & obstetrician, who specializes on women’s health, says, "menopause is not the end of woman's life". Thanks to the new drug Lynkuet, finally approved by the US Food and Drug Administration, women can now actually believe so. This is a nonhormonal medication, designed to treat hot flashes and night sweats in menopausal and perimenopausal women. The drug is developed by Bayer, and its main compound is elinzanetant. This is a novel therapy that could also help improve sleep disturbances commonly linked to menopause. Why Is This Medicine A Breakthrough?While most medicines treating menstrual-relating symptoms for women are heavy doses of hormones, leading to many side effects, Lynkuet stands out. It offers relief without using hormones, a much-needed alternative for women who cannot or prefer not to take hormone therapy. What's Wrong With Hormonal Drugs?while hormone replacement therapy (HRT), usually estrogen and progesterone, remain effective for many, it is not suitable for everyone. Women with a history or high risk of breast and ovarian cancer, or those wary of hormone-related side effects, often seek for better, safer and nonhormonal options. Until recently, those options were extremely limited. The first nonhormonal drug, Veozah (fezolinetant), was approved in 2023, targeting only one type of brain receptor linked to temperature regulation. Before that, doctors mostly relied on low-dose antidepressants like paroxetine to manage hot flashes, an off-label approach with limited benefits.How Does Lynkuet Work?What makes this medicine different is the way it works on the brain. The drug is responsible for blocking two types of neurokinin receptors, namely: NK1 and NK3. These neurokinin receptors play a key role in regulating body temperature, mood, and sleep. By doing so, elinzanetant helps restore balance in the hypothalamus, which is brain's temperature control center. This usually becomes disrupted when estrogen levels fall during menopause. This dual-action mechanism is what sets Lynkuet apart. Unlike Veozah, which targets only one receptor, elinzanetant’s two-receptor approach could mean broader benefits, not just reducing hot flashes and night sweats, but also improving sleep quality, which many women struggle with during perimenopause and menopause.How Did It Pass The Clinical Trials?Clinical trials for Lynkuet involved women aged 40 to 65 who experienced frequent and severe hot flashes. According to researchers, symptom relief began as early as one week after starting treatment.By week 12, over 70% of women taking elinzanetant reported at least a 50% reduction in the frequency of hot flashes, compared to just over 40% in the placebo group. Sleep quality also improved significantly, with many participants reporting fewer disturbances at night.At 26 weeks, the benefits persisted, more than 80% of participants maintained a 50% reduction in symptom frequency. Those who initially received the placebo and later switched to the drug showed similar improvements, underscoring its consistent efficacy.Are There Any Side Effects?The most common side effects reported are mild headache, fatigue, and joint pain. A few participants also reported elevated liver enzyme levels, however there was no serious toxicity observed.