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The new non-hormonal drug for hot flushes and night sweats, Fezolinetant, is part of an entirely new class of drug, the NK3 antagonists. Fezolinetant has now been approved for use in the UK, having been approved for use in the USA since May 2023.
Currently the non-hormonal options available for hot flushes and night sweats include
- epilepsy medications
- a blood pressure treatment
- a treatment for urinary urgency and incontinence.
It’s so great to see a new treatment option that has been specifically designed for supporting symptoms at menopause, because of course not everyone can or wants to take HRT.
Fezolinetant works on the part of the brain that acts like our thermostat, influencing changes in neurotransmitters which regulate the underlying mechanism that causes symptoms, reducing the number and intensity of hot flushes and night sweats for most people.
NK3 antagonists had remarkable effects for some people in the trials, “switching off” their hot flushes and night sweats within just a few days.Some people commented that their sleep improved as a result, but as NK3 antagonists do not affect oestrogen levels they would not be expected to improve any other symptoms of menopause.
What happens for a new drug to be prescribed?
When new drugs are developed there are vigorous procedures that are followed before they come to be prescribed by specialists or GPs.
Fezolinetant has been approved by the MHRA (Medicines & Healthcare products Regulatory Agency), who as their name suggests regulate medications in the UK. This means it will shortly be available to prescribe, initially only on a private basis.
A review by NICE (National Institute for Health and Care Excellence) is pending. NICE makes recommendations on the use of new and existing medicines and treatments within the NHS. These recommendations are based on a review of the available clinical and economic evidence.
Local areas will then review this guidance, and may make an application to their prescribing formulary for the inclusion of any new drug. This process decides whether a GP can initiate the new drug, or whether it will be recommended for specialist initiation only.
So who can take Fezolinetant?
- The licensing is for the treatment of moderate to severe vasomotor symptoms (hot flushes and night sweats).
- Participants in the studies were 40 to 65 years of age, so unfortunately currently it has not been studied for safety and effectiveness in those over the age of 65, so no dose recommendation will be made for this age group at present.
- It can be used by those with a diagnosis of breast cancer.
How is it taken?
Fezolinetant is a prescription only tablet, taken once daily, with or without food.
Liver blood test monitoring may be recommended for some people.
What about side-effects?
The most commonly reported side-effects in the studies were headache, diarrhoea, abdominal pain and difficulty sleeping.
Some people had changes in their liver function blood tests, that seemed to resolve when the drug was stopped. Other people noted changes in their blood glucose levels.
Medications are studied very closely before they come to be prescribed, and all new medications continue to be monitored closely, to allow for the prompt identification of any new safety information. Side-effects of drugs can also be reported by those who take them at yellowcard.mhra.gov.uk/.
So overall, a really welcome positive development that increases the options for us in moderating hot flushes and night sweats at menopause.