Latest news with #JulianBeach
Telegraph
4 days ago
- Health
- Telegraph
First nasal spray for allergic reactions now available in UK
The first needle-free emergency treatment for anaphylaxis – in the form of a nasal spray – will now be available in the UK. The Medicines and Healthcare products Regulatory Agency (MHRA) has approved the adrenaline (epinephrine) nasal spray (EURneffy) for emergency treatment. The manufacturer, ARS Pharma, has been contacted for comment about whether it plans to seek wider approval for use on the NHS. Julian Beach, MHRA interim executive director of healthcare quality and access, said: 'Patient safety is our top priority, which is why we're pleased to approve the first needle-free nasal spray formulation of adrenaline for the emergency treatment of anaphylaxis in the UK. 'Until now, adrenaline for self-administration has only been available via auto-injectors. 'While this represents an important new option, adrenaline auto-injectors remain a vital and potentially life-saving treatment, giving people experiencing anaphylaxis valuable time before emergency help arrives. 'We continue to encourage everyone at risk of severe allergic reactions, and those around them, to familiarise themselves with how to respond in an emergency. 'Resources and guidance are available on the MHRA website to help people be prepared.' Anaphylaxis is a sudden and life-threatening allergic reaction that can cause a drop in blood pressure and breathing difficulties. EURneffy is intended for use in adults and children who weigh 30kg (about 66lb) or more, and can be used even if people have colds or blocked noses. It is a single dose nasal spray that delivers its entire contents (2mg) upon activation. People are reminded that the plunger should not be pressed before inserting the product into the nostril, otherwise the single dose will be lost. The MHRA said patients should always carry two nasal sprays with them in case a second dose is needed, and tell family and friends where it is.
Telegraph
08-07-2025
- Health
- Telegraph
Non-HRT treatment for menopausal hot flushes approved
A treatment for menopausal hot flushes has been approved by medicine watchdogs. UK regulators have become the first in the world to approve the non-hormonal treatment, which is taken as a daily pill. Trials have found that elinzanetant (brand name Lynkuet) can cut flushes by two thirds and help to ease night sweats. Hot flushes are the most common symptom of menopause. Hormone replacement therapy is the most common form of medication used to combat menopausal symptoms. While HRT has become increasingly popular, many women do not want hormonal treatments which increase risk of cancer and some are not suitable for them. The new drug, now approved by the Medicines and Healthcare products Regulatory Agency (MHRA) is the first dual-action, non-hormonal pill to address both hot flushes and sleep problems. It has been licensed for the treatment of moderate to severe vasomotor symptoms (hot flushes) associated with the menopause. When oestrogen levels drop during menopause, certain brain cells become overactive and interrupt the body's ability to control temperature, which leads to hot flushes and night sweats. Elinzanetant is a new non-hormonal medication which works by calming these signals in the brain, helping bring the body's temperature control back into balance. It may also help improve sleep problems that often come with menopause. The medicine manufactured by Bayer is administered in oral tablet form. Julian Beach, MHRA interim executive director of healthcare quality and access, said: 'Hot flushes and night sweats associated with menopause can have a significant negative impact on quality of life. '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.' Elinzanetant's approval is based on results from the Oasis clinical trials, which involved more than 1,400 women aged 40 to 65 across several countries. These studies showed that taking a daily 120mg tablet of elinzanetant significantly reduced the number and intensity of hot flushes and night sweats over 26 to 52 weeks, compared with a placebo. At 12 weeks, hot flushes were reduced by around two thirds, the research found. By week 26, more than 80 per cent of women on elinzanetant achieved at least a 50 per cent reduction in hot flush frequency. In the past five years, the number of women taking HRT has doubled, with an estimated 2.6 million women using it in 2023-24. Much of the surge is attributed to the 'Davina' effect after Davina McCall spoke about her own experiences of menopause, and led campaigns about the symptoms and potential benefits of HRT. The numbers on the therapy had fallen sharply, after a landmark trial which was later found to have overstated the risks of breast cancer.
Rhyl Journal
08-07-2025
- Health
- Rhyl Journal
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 👉 — 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.
Glasgow Times
08-07-2025
- Health
- Glasgow Times
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 👉 — 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.
Leader Live
08-07-2025
- Health
- Leader Live
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 👉 — 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.
