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FDA approves new menopause drug to treat hot flashes and night sweats

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The FDA has approved elinzanetant, a new non-hormonal treatment for menopause that reduces hot flushes and night sweats.

Clinical trials in the US, Europe and Israel found the drug significantly reduced both the frequency and severity of hot flushes while improving women’s sleep and quality of life.

The approval follows successful results from the double-blind Oasis trials, led by UVA Health and other international research partners.

The studies enrolled postmenopausal women aged 40 to 65 with moderate to severe hot flushes, randomly assigning them to receive either 120mg of elinzanetant daily for 26 weeks or a placebo for 12 weeks followed by 14 weeks of the drug.

Women who received the treatment reported rapid improvements, with statistically significant reductions in the frequency and intensity of hot flushes within the first week.

By week 12, sleep quality and overall quality of life had also improved across both trials.

JoAnn V. Pinkerton is director of midlife health at UVA Health and US lead for the Oasis II trial.

Pinkerton said: “More than a third of women experience disruptive menopausal symptoms that can persist for more than a decade, significantly impacting work, home and quality of life.

“Many symptomatic menopausal women continue to suffer without treatment and support.

“With the FDA approval of elinzanetant, women will have access to a new, safe and effective therapy for relief of hot flushes and night sweats.

“Due to its dual receptor antagonism, the studies also showed improvements in sleep and mood.”

Hot flushes are caused by a drop in oestrogen levels during menopause, which affects how the brain regulates body temperature.

Hormone therapy remains the most effective treatment, but it can cause side effects such as breast tenderness, bloating, headaches or spotting.

In rare cases, long-term hormone use, particularly oral therapy, can raise the risk of blood clots, strokes or certain cancers such as uterine cancer if oestrogen is used without a uterine antagonist — a drug that blocks its effects on the womb.

Some women cannot take hormone therapy due to contraindications such as a history of blood clots or oestrogen-sensitive cancers.

Elinzanetant works through dual receptor antagonism, blocking two receptors involved in temperature regulation and other menopausal symptoms.

The most common side effects seen in the trials were mild headache and fatigue. No serious side effects were reported.

Pinkerton said: “I am excited that women who can’t or choose not to take hormone therapy will have access to elinzanetant, which is an effective and tested, FDA-approved therapy for bothersome symptoms.

“It’s critical that we listen to our patients to understand exactly what they are experiencing and then help them get the support they need, tailored to their individual needs.”

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Government and NHS urged to work with pharmacies on menopause support

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The government and NHS England should work with pharmacies to show how the sector can help women experiencing menopause symptoms, according to a joint statement released by several pharmacy bodies.

A consensus statement endorsed by the Royal College of Pharmacy warned there remains significant unmet need for clear, evidence-based guidance and advice on the condition.

The statement, ‘Menopause, unmissed’, published on 24 April 2026, was endorsed by bodies including the Royal College of Pharmacy, the Company Chemists’ Association and the National Pharmacy Association.

Amandeep Doll, director for England at the Royal College of Pharmacy, said: “Pharmacy teams are highly accessible and already support people experiencing menopause with advice, self-care and signposting to other services.

“We endorsed this statement because improving access to clear information and joined-up care is essential, particularly for those facing inequalities.”

According to the NHS, around 75 per cent of women experience some symptoms during perimenopause and menopause, while 25 per cent report that their symptoms are severe.

In the joint statement, the pharmacy bodies welcomed increased awareness of menopause in recent years but warned this had also led to a sea of misinformation and that there remains significant unmet need, particularly for clear, evidence-based and accessible information and guidance.

The document set out eight recommendations to improve menopause care, including a public awareness campaign on menopause symptoms and opportunities for self-care, alongside guidance on how pharmacies can support women with menopause.

It also recommended that integrated care boards and women’s health hubs should report progress on implementing the upcoming equity framework in menopause care.

In its renewed women’s health strategy for England, published on 15 April 2026, the Department of Health and Social Care set out plans to publish an equity good practice guide to help integrated care boards better understand and reduce inequalities in heavy periods and menopause.

The joint statement asked that the Department of Health and Social Care and NHS England work with champions in minority communities to ensure menopause materials reflect a diverse range of experiences.

It added that women living in areas of high deprivation and those from Black, Asian and minority ethnic communities can experience menopause differently and are more likely to face health inequalities in their care.

Doll said: “With the right support, training and commissioning, community pharmacy can play a greater role in delivering timely, convenient menopause care closer to home, working as part of neighbourhood health teams and in partnership with women’s health hubs.”

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HRT maker censured by regulators for ‘systemic failures’ that risked patient safety

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Theramex has been censured over HRT failures that regulators said jeopardised patient safety.

The UK producer of HRT drugs, including Evorel and Intrarosa, was found to have breached fundamental compliance standards.

These included not updating crucial prescribing information, in some cases for several years, and not making clear that one drug must not be used during pregnancy.

The Prescription Medicines Code of Practice Authority issued the public reprimand after Theramex staff blew the whistle over what it described as “alarming” compliance issues and incomplete prescribing information for Evorel and Intrarosa that “jeopardise patient safety”.

Evorel patches, which contain estradiol, are among the most prescribed forms of transdermal HRT, meaning hormone treatment delivered through the skin. More than 250,000 items were issued in the last financial year, according to NHS Business Services Authority figures.

Overall, nearly 10m items of estradiol, including gels, were prescribed in the 2024/25 financial year.

The employees’ concerns included failing to provide comprehensive side-effect information in Evorel’s prescribing information, and not updating Intrarosa’s product information since 2019.

The PMCPA also reprimanded the company over failures to specify in advertising at a reproduction and advertising conference that Yselty, used to treat uterine fibroids, should not be taken during pregnancy.

In total, the PMCPA found Theramex had breached the Association of the British Pharmaceutical Industry’s code of practice 21 times.

The panel said the breaches not only jeopardised patient safety, but that Theramex had “brought discredit upon, and reduced confidence in, the pharmaceutical industry”.

The PMCPA also condemned Theramex’s decision to leave the regulator’s jurisdiction.

“By leaving the self-regulatory framework and requiring the Medicines and Healthcare products Regulatory Agency to assume full responsibility for regulating it, Theramex has inevitably delayed any regulatory action and oversight,” it said.

Dr Amit Aggarwal, medical director of the ABPI, said: “Theramex has fallen seriously short of the standards expected under our strict ABPI code of practice, and it’s right that the PMCPA took action.

“It’s also disappointing that as a result, the company has decided to leave the pharmaceutical industry’s self-regulatory system, which holds companies to standards above and beyond the law.”

Julian Beach, MHRA’s executive director of healthcare quality and access, said he was disappointed Theramex had left the PMCPA, but that the MHRA would take any necessary steps to ensure patient safety.

He said: “Leaving the jurisdiction of the PMCPA does not mean a company escapes scrutiny.

“The MHRA has legal powers to investigate and act on concerns about medicines that may impact public safety. Breaches of regulations can amount to criminal offences.”

A spokesperson for Theramex said: “Upholding ethical standards, compliance, and patient safety is very important to us. We acted promptly to address these historical matters as soon as we became aware of them.

“We take these matters seriously and have undertaken a comprehensive review of our compliance framework, including commissioning an independent external audit and implementing a broad programme of enhancements.

“As part of this process, we concluded it is most appropriate to be regulated with respect to UK medicines legislation by the MHRA, while continuing to uphold the spirit and principles of the EFPIA and ABPI codes of practice.

“Therefore, we withdrew from the PMCPA’s jurisdiction in January 2026. This approach allows us to focus our resources on maintaining high standards of ethical and compliant behaviour, with patient safety.”

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Menopause

Uni initiative tackles women’s health crisis

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A University of Sheffield initiative is tackling overlooked women’s health problems by helping students develop solutions to delays and inequalities in care.

In a first-of-its-kind collaboration bringing together students, clinicians and industry leaders, new ideas have been developed to address health challenges that leave millions of women facing years-long delays in diagnosis and care.

The Women’s Health Innovation Challenge saw 50 students from across disciplines and year groups work in teams on issues including fragmented care across the female health lifecycle and the widespread normalisation of serious symptoms.

Among the key challenges explored was endometriosis, a condition affecting one in 10 women globally, where patients in the UK face an average diagnosis time of more than nine years.

Other innovations addressed gaps in menopause care, cardiovascular health in women and the fragmentation of digital health solutions across different life stages.

The initiative reflects the university’s growing work in women’s health innovation, a field widely recognised as underfunded and underserved despite affecting half the global population, and its commitment to turning research and ideas into meaningful impact.

Rachel Kovacs, a final year biomedical engineering student at the University of Sheffield and organiser of the event, said: “I was lucky enough to be one of the students to take the first Women’s Health in Biomedical Engineering module in the UK, right here in Sheffield, and it really opened my eyes to how under-innovated the field is.

“I only discovered this in my final year and I wanted other students to find it sooner.

“The event itself has already made a huge difference. Students now see women’s health as a space worth innovating in.

“If even a handful take their ideas further, we could genuinely change women’s lives.

“Having personally experienced some of these gaps, I know the impact this could have on women across the globe.”

The event was supported by experts from across research, industry and healthcare, including panel members from Health Innovation Yorkshire & Humber, an NHS England organisation which acts as a bridge between healthcare providers, commissioners, academia and industry.

Participants explored a range of possible solutions to some of the sector’s most complex challenges.

The event culminated in students pitching their ideas to a panel including clinicians, academic researchers and founders of women’s health startups, creating a direct link between emerging innovation and real-world application.

The challenge forms part of the university’s wider activity in this space, including its Women’s HealthTech Innovation Network, which brings together regional and national expertise to translate research into solutions that address longstanding inequalities in care.

Dr Vanessa Hearnden, senior lecturer in biomaterials and tissue engineering at the University of Sheffield and co-chair of the Women’s HealthTech Innovation Network, said: “The Women’s Health Innovation Challenge gave students a rare opportunity to work directly with clinicians, researchers and industry partners to tackle real-world problems.

“The quality of ideas and level of engagement demonstrated the impact this kind of interdisciplinary, challenge-led learning can have.”

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