The recent New Drug Application (NDA) submission for elinzanetant marks an important development in non-hormonal treatments for vasomotor symptoms (VMS), including hot flashes, which are common during menopause. Elinzanetant is a pioneering dual neurokinin-1 and 3 (NK-1 and NK-3) receptor antagonist, taken orally once a day. Bayer’s NDA submission to the U.S. Food and Drug Administration (FDA) for elinzanetant relies on data from three comprehensive Phase III clinical trials, known as OASIS 1, 2, and 3, which all demonstrated the compound’s effectiveness and safety.
In these studies, published in August 2024 in JAMA and presented at The Menopause Society’s annual conference in September, researchers explored elinzanetant’s impact on moderate to severe VMS. These trials spanned multiple sites worldwide, with OASIS 1 and 2 focusing on VMS relief over 26 weeks, while OASIS 3 provided longer-term safety and efficacy data across 52 weeks. These studies enrolled nearly 1,500 women aged 40 to 65, testing elinzanetant against a placebo and providing a thorough assessment of its potential benefits. An additional study, OASIS 4, is extending research to address VMS specifically for women undergoing endocrine therapy due to breast cancer.
Bayer is further evaluating elinzanetant in the NIRVANA Phase II trial, targeting its effects on menopause-related sleep disturbances. This study employs polysomnography (PSG), a detailed sleep evaluation method, to better understand how elinzanetant might alleviate sleep disruptions that frequently accompany menopause, thereby offering a multi-symptom treatment option for women.
Understanding Vasomotor Symptoms (VMS)
VMS are primarily driven by changes in the hypothalamus, where estrogen-sensitive neurons—known as KNDy neurons—are located. Reduced estrogen levels lead to the hyperactivation of these neurons, disturbing thermoregulatory pathways and causing hot flashes. Affecting up to 80% of women during menopause, VMS can significantly impact daily life, sometimes lasting a decade or longer. Current estimates suggest that over one-third of menopausal women suffer severe VMS, highlighting an urgent need for effective, non-hormonal treatments.
The Growing Impact of Menopause Worldwide
With approximately 1.2 billion women expected to be in menopause by 2030, and an estimated 47 million entering this phase annually, menopause management is an increasingly critical area of healthcare. Symptoms like VMS, mood changes, and sleep disturbances can disrupt health, quality of life, and productivity, affecting both personal and socio-economic domains.
Elinzanetant could provide a valuable solution, especially as current treatment options for VMS are limited, particularly for women with a history of breast cancer.
Future Directions
Bayer is actively pursuing regulatory approvals for elinzanetant across multiple regions, aligning with a broader movement to offer non-hormonal treatment alternatives for VMS. If approved, elinzanetant could represent a landmark in menopause care, expanding the choices available to women seeking effective symptom management without hormone therapy.
By supporting daily functionality and enhancing quality of life, elinzanetant holds promise not only as a therapeutic advance but as a potential catalyst for expanding research and healthcare options for women in menopause.
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