Medication for hot flushes to be available in Ireland by April

Medication for hot flushes to be available in Ireland by April

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A new menopause drug to treat hot flushes is expected to be available in Ireland by April.

Veoza, which was recently approved by the European Medicines Agency (EMA), is “a really powerful weapon” to tackle hot flushes, said Deirdre Lundy, who heads up the Menopause Clinic located in the National Maternity Hospital.

She is hopeful the drug can particularly help women with breast cancer who are unable to use hormone replacement therapy (HRT) to control hot flushes and other symptoms.

“We’re hoping that by March, April we will have it available,” said Dr Lundy.

“This drug just shuts down fluctuations in heat and sweating at a brain level, so it’s very effective. 

"There is an area in the brain that controls your core temperature and how that impacts your skin temperature, and whether you are sweating or not. For women, this is very sensitive to changes in female hormones.” 

Many women use HRT to treat hot flushes, but Dr Lundy said: “That is fine for almost everybody but not fine for people diagnosed with a hormone-sensitive cancer.” 

Women can have “debilitating sweats" 30 to 40 times a day, she said, and at night, it can lead to chronic sleep deprivation.

Clinical trial participants did not include breast cancer patients, but Dr Lundy expects to offer it as an option.

However, she cautioned that it "probably won’t" get support from the drugs payment scheme so it "won’t be cheap” but she is hopeful the product could be approved for public funding later.

Veoza does not directly target mood or brain fog in the way HRT can do.

I would say if someone has had chronic sleep disruption and now gets a week of solid seven to eight hours a night, you watch how that mood improves or how that brain fog gets better." 

The manufacturer, Astellas, said Veoza targets moderate to severe vasomotor symptoms — hot flushes and night sweats — in menopause.

The company said it is suitable for women with contraindications to HRT, those who are averse to taking HRT, have stopped taking it, or who have conditions that suggest caution in using hormone therapy.

In Ireland, the Health Products Regulatory Authority (HPRA) is responsible for authorising medication.

A spokesman said Veoza/Fezolinetant was recently approved by the EMA.

“In turn, the HPRA is actively progressing with HPRA approval activities, which we aim to complete in the coming weeks,” he said.

It was authorised for use in Europe just before Christmas by the EMA, based on clinical trial findings.

These showed after one month of treatment the number of moderate to severe daily hot flushes was cut by 53% on average for participants compared to 32% for participants taking a placebo.

The severity of hot flushes was also reduced. 

The EMA noted that side effects include diarrhoea and difficulty sleeping but it was found, on balance, that the benefits are greater than the risk.

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