A recent study published in the Journal of the American Medical Association (JAMA) highlights the potential of elinzanetant, an investigational drug, to significantly reduce the frequency and severity of hot flashes in menopausal women. This non-hormonal treatment also demonstrated the ability to improve overall quality of life, offering a promising new option for those struggling with disruptive menopausal symptoms.
Menopause is a natural phase in a woman’s life, but it often comes with a variety of uncomfortable symptoms. Vasomotor symptoms (VMS), commonly known as hot flashes, and sleep disturbances are among the most prevalent. Up to 80% of women report experiencing hot flashes, while 60% endure sleep disruptions. These symptoms can severely impact daily life, leading to decreased productivity, strained personal relationships, and a general decline in well-being.
Elinzanetant functions as a neurokinin 3 receptor (NK3R) antagonist, targeting NK3 receptors in the hypothalamus—a brain region responsible for regulating body temperature. During menopause, the decline in estrogen levels can disrupt this temperature regulation, leading to hot flashes. By blocking NK3R, elinzanetant helps restore temperature control, thereby reducing the frequency and severity of hot flashes. This mechanism provides a non-hormonal alternative for managing menopausal symptoms, which is particularly beneficial for women who cannot or choose not to take hormone therapy.
The efficacy and safety of elinzanetant were evaluated in two large phase 3 clinical trials, Oasis 1 and 2. These trials were conducted across various United States, Europe, and Israel locations, including the University of Virginia (UVA) Health. The trials enrolled postmenopausal women aged 40-65 who were experiencing moderate to severe hot flashes. Participants were randomly assigned to receive either 120 mg of elinzanetant daily for 26 weeks or a placebo for 12 weeks, followed by 14 weeks of elinzanetant.
The results from these trials were highly encouraging. Women taking elinzanetant experienced rapid improvements in their symptoms and overall quality of life. Statistically significant reductions in the frequency and severity of hot flashes were observed within the first week of treatment. By the 12th week, improvements in both sleep quality and overall quality of life were noted across both trials. Simon et al., in their clinical trial (SWITCH-1), concluded that elinzanetant is an effective and well-tolerated non-hormonal treatment option for postmenopausal women with VMS and associated sleep disturbances. Additionally, elinzanetant demonstrated a positive impact on the quality of life for women suffering from these symptoms.
Furthermore, Pinkerton et al. emphasized the potential of elinzanetant as a non-estrogen treatment for women with bothersome menopausal symptoms. The drug’s effectiveness in relieving hot flashes in highly symptomatic women, along with improvements in sleep and mood across multiple trials, and its favorable safety profile, suggest that elinzanetant could become a valuable non-estrogen option for treating menopausal symptoms.
In addition to its efficacy, the researchers closely monitored the drug’s safety profile. The most commonly reported side effects were mild, including headaches and fatigue, with no severe adverse effects reported. This reassuring safety profile further supports the potential of elinzanetant as a viable treatment option.
The study underscores the growing need for non-hormonal treatments for menopausal symptoms, particularly for women who are unable or unwilling to take hormone therapy due to health concerns or personal preferences. The researchers highlighted the importance of expanding treatment options for menopausal women, stating that there is a significant unmet need for new therapies to alleviate the burden of hot flashes and other symptoms. As the search for safe and effective treatments for menopausal symptoms continues, elinzanetant represents a promising development. Its ability to reduce hot flashes, improve sleep, and enhance overall quality of life, all without the use of hormones, makes it a compelling option for women seeking relief from the challenges of menopause.
References
- Pinkerton JV, Simon JA, Joffe H, Maki PM, Nappi RE, Panay N, et al. Elinzanetant for the Treatment of Vasomotor Symptoms Associated With Menopause: OASIS 1 and 2 Randomized Clinical Trials. JAMA [Internet]. 2024 Aug 22 [cited 2024 Aug 29]; Available from: https://doi.org/10.1001/jama.2024.14618
- Simon JA, Anderson RA, Ballantyne E, Bolognese J, Caetano C, Joffe H, et al. Efficacy and safety of elinzanetant, a selective neurokinin-1,3 receptor antagonist for vasomotor symptoms: a dose-finding clinical trial (SWITCH-1). Menopause. 2023 Mar;30(3):239–46.