Hot flush pill gets green light for UK use
The Medicines and Healthcare products Regulatory Agency (MHRA) said it is the first regulator in the world to approve elinzanetant, also known as Lynkuet.
The treatment, made by Bayer, can be given to women who have vasomotor symptoms, also known as hot flushes, as an alternative to hormone replacement therapy (HRT).
HRT can help relieve most menopause and perimenopause symptoms, including hot flushes.
But not all patients want or are able to take hormone treatments.
At present elinzanetant is not available on the NHS but the green light from the MHRA means that it can be purchased privately in the UK.
It is to be considered by the NHS spending watchdog, the National Institute for Health and Care Excellence.
Hot flushes and night sweats are one of the most common symptoms of menopause.
It is understood that as oestrogen levels decline around menopause, the body's temperature regulation system can be disrupted when certain brain cells become overactive.
The new treatment, which is a non-hormonal medication, works by calming these signals in the brain.
Clinical trial data showed that the drug was safe and well tolerated and reduced hot flushes compared with a dummy drug, also known as a placebo.
You may not have reached #menopause if you're experiencing headaches, night sweats, weight gain, anxiety and depression – but you may be #perimenopausal. Take a look on our website for more information 👉 https://t.co/hw2P09ZPA6 pic.twitter.com/zvbXIWXh3C
— Patient (@patient) May 22, 2023
It was also linked to fewer sleep disturbances and women taking it reported a better quality of life compared with those taking the placebo.
'Hot flushes and night sweats associated with menopause can have a significant negative impact on quality of life,' said Julian Beach, the MHRA's interim executive director of healthcare quality and access.
'We are therefore pleased to announce our approval of elinzanetant, which has met the MHRA's standards for safety, quality and effectiveness.
'Elinzanetant offers a non-hormonal alternative for those who may not be able to, or prefer not to, take hormone-based therapies.
'As with all licensed medicines, we will continue to monitor its safety closely as it becomes more widely used.'
Women usually go through the menopause when they are aged between 45 and 55, though it can start sooner.
During the menopause a woman's periods stop due to lower hormone levels.
Menopause and perimenopause can cause symptoms including anxiety, mood swings, brain fog, hot flushes and irregular periods.
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