18 October 2024

Emerging therapeutics and technology provide hope for menopause management

Historically, women’s health has been greatly underfunded and under-researched. Nowhere is this gender-biased neglect more evident than in the research and clinical management of menopause symptoms. In response, World Menopause Day, held every year on 18 October, aims to raise awareness of the symptoms and impact of menopause and highlight the options available for supporting those going through the menopause transition.

The World Health Organisation (WHO) defines menopause as “the permanent cessation of menstruation resulting from loss of ovarian follicular activity”.

In the UK, the average age for menopause is 51. However, spontaneous (natural) early menopause affects approximately 5% of the population before the age of 45 whilst premature menopause, defined as menopause before the age of 40, occurs in approximately 1% of women. It has been estimated that over one billion women globally will be perimenopausal or postmenopausal by 2030 and nearly 50 million people are expected to reach menopause each year.

Whilst a natural part of ageing, menopause often has a significant impact on personal, social and professional quality of life. Alarmingly, research from the Fawcett Society indicates that 10% of women have left the workplace due to the symptoms of menopause whilst a 2019 survey found that three in five menopausal people were negatively affected at work.  

Classic symptoms of menopause include hot flushes (vasomotor symptoms), mood changes such as anxiety and depressive symptoms, urogenital symptoms including sexual dysfunction, incontinence and urinary tract infections, disturbed sleep, impaired verbal memory and musculoskeletal pain. For many, these symptoms are severe and debilitating. Even those who do not experience severe symptoms are at risk of long-term effects including increased risk of cardiometabolic disease, diabetes, bone loss and cancers associated with increased abdominal fat (e.g., breast, colon and endometrial cancer).

Symptoms are likely underdiagnosed and undertreated. For many, hot flushes are the only symptom they attribute to menopause, meaning that other symptoms are left inadequately managed. Many are hesitant to ask for help in case their symptoms are dismissed by medical professionals as a normal part of ageing.

Nevertheless, pharmacological treatments are available. The gold standard treatment for menopause symptoms is hormone replacement therapy (HRT), which aims to replace hormones lost during the menopause transition (i.e., oestrogen and progesterone). However, patient confidence in the safety of HRT was severely damaged following the publication of the 2002 Women’s Health Initiative (WHI) study and the 2003 UK Million Women Study (MWS) which first linked HRT to increased risk of blood clots and stroke and a small absolute increased risk of breast cancer respectively. The resultant decline in HRT prescribing cast doubt over the commercial returns within the women’s health sector. As such, pharmacological innovation for menopause treatment has largely been limited to novel combinations of oestrogen and progesterone (e.g. synthetic or bioidentical forms) and formulations optimised for different routes of administration (e.g., oral tablets, patches, suppositories, gels or sprays).

More recently, interest in the menopause market has been piqued by the success of novel nonhormonal therapies such as fezolinetant. This next generation of therapeutics stems from the research of neuropathologist Prof Naomi Rance, who identified a specific group of neurons in the hypothalamus (a part of the brain that controls body temperature) that become overactive and enlarged in the brains of menopausal people. However, whilst fezolinetant has been approved by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) and is currently available via private prescription, it is not yet available via the National Health Service (NHS).

Faced with “medical gaslighting” and a dearth of suitable therapeutics, tech-savvy women are increasingly taking matters into their own hands and turning to technology to ease their menopause symptoms; the result being a boom in the FemTech (“female technology”) industry and rich pickings for innovators.

A notable example is Vira Health’s Stella app, which aims to provide a personalised treatment plan (for example, cognitive behavioural therapy, sleep scheduling, pelvic floor exercises) based on specific symptoms, machine learning, and lifestyle preferences. Devices aimed at relieving the symptoms of hot flushes include the Menopod, which was featured on an episode of Canadian Dragons Den, and the Thermaband Zone.

In such a rapidly growing market, innovators would be wise to develop a strategy for protecting and exploiting their intellectual property at an early stage. If in doubt, your patent attorney will be able to guide you.