FDA approves treatment for menopausal hot flushes

Four women go walking

Image credit: sk via Unsplash

Last month, the first drug of its kind known as Veozah (fezolinetant), was approved by the FDA for non-hormonal treatment of hot flushes commonly accompanying menopause. 

For women aged between 40–55, the menopause transition brings a range of symptoms associated with the decrease in oestrogen levels as menstruation ends. Symptoms of this hormonal change vary with both intensity and duration but typically include fatigue, anxiety, headaches, and hot flushes.

Hormonal fluctuation disrupts the body’s thermoregulation and directly affects the hypothalamus, the region of the brain responsible for controlling body temperature. The hypothalamus mistakenly senses overheating and signals the body to cool down by dilating blood vessels, increasing heart rate and sweating resulting in a hot flush. Around 80% of menopausal women experience hot flushes, and though they may sound like just a nuisance, they can ravage sleep patterns, socialising and exercise leaving lasting impacts on women’s overall health. 

‘Hot flushes can ravage sleep patterns, socialising and exercise

Until now, all the most effective treatment available for the menopause is hormonal replacement therapy, which replaces oestrogen (and occasionally other hormones) as their natural production slows. However, this treatment is not suitable for all patients, as for women with a history of stroke, migraines and some breast cancers it may do more harm than good. The recent development of Veozah represents a significant advancement for women’s health and the treatment of female-only conditions.

With the advent of modern medicine, this is the first non-hormonal drug for a condition that affects all women sooner or later in their lives. Limited treatment options for decades have created a gaping “unmet need” which is finally being tackled. ‘When you think about the impact of vasomotor symptoms on work, on cognitive function, on sleep, on quality of life—the availability of another option is exciting… This is something we’ve been anticipating for a long time,’ says Dr Lauren Streicher, a clinical professor of obstetrics and gynaecology at Northwestern University, Illinois and medical director of the Northwestern Medicine Centre for Menopause. 

‘This is something we’ve been anticipating for a long time’

Dr Lauren Streicher, Northwestern University

The newly approved drug Veozah is the first to target a neuron in the brain. The neuron receptor targetted will normally inappropriately activate heat dissipation responses in the hypothalamus when oestrogen levels fall. When oestrogen levels fall at the menopause transition, ‘these neurons go into overdrive,’ says Dr Streicher, forcing the body to perceive it is hotter than normal. This sets of the cascade of cooling events which culminates in the hot flush.

Taken orally, this treatment is a neurokinin 3 (NK3) receptor agonist which binds and blocks the NK3 receptor in the brain. As with most medications there are risks associated with taking the drug, here the main concern is liver toxicity. The FDA recommends women with known liver damage to avoid the drug and all women who do go on the drug should have blood work done first to screen for the damage. It is expected that these will become apparent once the drug is on the market and is used by more patients over a longer timeframe.