Bayer expects its latest menopause relief drug to be out soon

Menopause-related health problems, both physical and mental, have become a pressing issue for women at the transformative age worldwide. Modern lifestyle diseases exacerbate these conditions, making menopause even more challenging for many women.

Hot flashes are the most common yet complex symptom of menopause, characterized by sudden, intense feelings of heat, primarily affecting the face, neck, and chest. These episodes are often accompanied by sweating and may sometimes be followed by chills. Typically lasting from a few seconds to several minutes, hot flashes are linked to hormonal fluctuations, particularly a drop in estrogen. Other associated symptoms include flushing, rapid heartbeat, fatigue, irritability, and forgetfulness. When these episodes occur at night, they are referred to as night sweats, which can disrupt sleep. The underlying cause of hot flashes is believed to be changes in the brain’s thermoregulatory center.

Managing hot flashes involves lifestyle adjustments, such as staying cool and avoiding known triggers. In some cases, medications like hormone therapy may also be recommended under the guidance of a healthcare provider.

While hormone therapy remains one of the most effective treatments for alleviating many menopause-related symptoms, particularly for vasomotor symptoms, it is not suitable for everyone.

For women who cannot or choose not to take hormone therapy, non-hormonal treatments are available. These include selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), and gabapentin, which can be effective for managing hot flashes and mood swings.

Medications like bisphosphonates or denosumab are used to prevent and treat osteoporosis in postmenopausal women.

German drug maker Bayer, which is awaiting regulatory approval for its new drug, elinzanetant, expects it to hit the market soon. This latest non-hormonal treatment is anticipated to be superior to existing options, offering a simpler regimen compared to many hormone therapies.

Bayer has on Tuesday announced plans to launch elinzanetant by late summer this year. The company continues to submit applications for marketing authorizations for elinzanetant to health authorities worldwide.

By 2030, it is estimated that 401 million women in India, aged 45 and older, will enter menopause, representing a significant portion of the global postmenopausal population. This transition often brings various health challenges, including an increased risk of cardiovascular disease, osteoporosis, and mental health issues.

Globally, the number of women experiencing menopause is expected to rise to 1.2 billion by 2030, with 47 million women entering this phase each year. Menopause is a transitional phase marked by the progressive decline of ovarian function, typically occurring in women during their 40s or early 50s. It can also result from surgical or medical treatments, such as breast cancer therapy.

The hormonal changes associated with menopause can lead to various symptoms that significantly impact a woman’s health, quality of life, healthcare utilization, and work productivity. Among the most frequently reported and disruptive symptoms during the menopausal transition are vasomotor symptoms (VMS), sleep disturbances, and mood changes. Addressing these symptoms is essential for maintaining functional ability and quality of life during menopause, which has important healthcare and socio-economic implications.

In October 2024, Bayer said that the US Food and Drug Administration (FDA) had accepted the company’s New Drug Application (NDA) for elinzanetant. The application states that it is a treatment for moderate-to-severe vasomotor symptoms (VMS) associated with menopause.

“The NDA acceptance of elinzanetant by the FDA marks a significant step forward in advancing menopause care for women in the U.S. If approved, elinzanetant will offer a new non-hormonal treatment option for women seeking relief from moderate to severe vasomotor symptoms,” stated Christine Roth, the company’s Executive Vice President of Global Product Strategy and Commercialisation, emphasising the significance of this milestone, in October.

The NDA submission for elinzanetant was based on positive results from its primary and phase III studies. Findings from these trials were published in August 2024 in the Journal of the American Medical Association. These data, which provided supporting efficacy and long-term safety details, were also presented at The Menopause Society’s (TMS) annual meeting in September 2024.