The experimental drug elinzanetant has been found to alleviate hot flashes while enhancing women’s sleep and overall well-being, according to a new study.
Recent research from UVA Health published in the Journal of the American Medical Association indicates that the investigational medication elinzanetant significantly lessens the occurrence and intensity of hot flashes linked to menopause, leading to improvements in women’s quality of life.
This nonhormonal medication, which does not contain estrogen, was evaluated through two phase 3 trials known as Oasis 1 and 2, conducted at numerous sites across the United States, Europe, and Israel, including UVA Health. Postmenopausal women aged 40 to 65 experiencing moderate to severe hot flashes were randomly assigned to receive either 120 mg of elinzanetant daily for 26 weeks or a matching placebo for 12 weeks, followed by 14 weeks on elinzanetant.
The participants who took elinzanetant reported quick improvements in their symptoms and overall quality of life. The trials demonstrated significant decreases in the frequency and intensity of hot flashes within the first week across both studies. Additionally, both sleep quality and general quality of life saw improvements by the 12-week mark.
“The efficacy of elinzanetant in providing relief for severely symptomatic women, along with enhancements in sleep and mood observed in multiple trials and its favorable safety profile, suggest that it may be a valuable non-estrogen treatment for women experiencing troublesome menopausal symptoms,” stated JoAnn V. Pinkerton, MD, director of midlife health at UVA Health. “Elinzanetant acts as a dual neurokinin receptor antagonist, meaning it targets two brain receptors to alleviate hot flashes, night sweats, sleep issues, and mood disturbances.”
Hot Flash Treatment
Hot flashes occur due to reduced estrogen levels during menopause and may continue for years for some women. While there are existing treatments, like hormone therapy, not all women can tolerate them, or they may choose to avoid them due to possible side effects. This has led researchers to emphasize the necessity for new, effective nonhormonal alternatives.
“There is a significant unmet demand for new treatments addressing hot flashes. Many menopausal women either cannot take hormone therapy for health reasons or opt not to, necessitating more non-estrogen strategies to alleviate their distressing hot flashes and sweats, which are known to impact both workplace performance and personal relationships,” remarked Pinkerton, who is also a professor of obstetrics and gynecology at the University of Virginia School of Medicine and the executive director emeritus of the North American Menopause Society. “Sleep disturbances rank among the most troublesome symptoms reported by menopausal women, affecting their mood, energy levels, and overall quality of life.”
Pinkerton and her team examined elinzanetant in the double-blind Oasis studies to determine its safety and efficacy as a new treatment for women suffering from hot flashes. (“Double-blind” means that neither the participants nor the researchers knew which subjects were receiving the drug or placebo until after the study was completed.)
The researchers also monitored possible side effects along with evaluating the drug’s impact on hot flashes, sleep issues, and quality of life. The most frequently reported side effects were mild headaches and fatigue, with no severe adverse effects reported, suggesting strong safety for the drug.
“I am enthusiastic about the potential of elinzanetant to be a nonhormonal treatment alternative for women facing significant menopausal symptoms who are unwilling or unable to use hormone therapy,” Pinkerton expressed. “I hope it could become a safe and effective non-estrogen solution for menopausal women experiencing a combination of moderate to severe vasomotor symptoms, sleep disruptions, and diminished quality of life related to menopause.”
Findings Published
The paper published in JAMA lists authors Pinkerton, James A. Simon, Hadine Joffe, Pauline M. Maki, Rossella E. Nappi, Nick Panay, Claudio N. Soares, Rebecca C. Thurston, Cecilia Caetano, Claudia Haberland, Nazanin Haseli Mashhadi, Ulrike Krahn, Uwe Mellinger, Susanne Parke, Christian Seitz, and Lineke Zuurman. Pinkerton has served as a consultant for Bayer; a full disclosure of the authors’ affiliations is included in the publication.
The funding for the Oasis trials was provided by Bayer.
