The US Food and Drug Administration (FDA) has granted approval for a novel menopause medication, elinzanetant, designed to alleviate hot flashes and night sweats. This decision follows successful trials conducted at UVA Health and other international locations. Elinzanetant, a non-hormonal drug, is particularly significant for women who are unable or unwilling to use existing hormone therapies due to potential side effects. According to Dr. JoAnn V. Pinkerton, Director of Midlife Health at UVA Health, the drug offers a safe and effective new treatment option.
Dr. Pinkerton, who led the US segment of the Oasis II clinical trial, highlighted the prevalence of disruptive menopausal symptoms affecting over a third of women, often persisting for over a decade. The trial demonstrated that elinzanetant significantly reduces the frequency and severity of hot flashes and enhances sleep quality and mood due to its dual receptor antagonism. She noted that many women suffer without adequate treatment, making this FDA approval a crucial development.
Menopause-related hot flashes are typically triggered by reduced estrogen levels. While hormone therapy is the most effective treatment, it carries risks such as blood clots, stroke, and certain cancers, particularly in long-term use. These risks, along with contraindications like a history of blood clots or estrogen-sensitive cancers, limit the use of hormone therapy for many women.
The Oasis trials, conducted across the US, Europe, and Israel, involved postmenopausal women aged 40-65 with moderate to severe hot flashes. Participants were randomized to receive either 120 mg of elinzanetant daily for 26 weeks or a placebo for 12 weeks followed by 14 weeks of elinzanetant. The trials reported rapid symptom improvement, with significant reductions in hot flash frequency and severity within the first week and improved sleep quality by week 12.
The trials also assessed potential side effects, identifying mild headache and fatigue as the most common. No severe side effects were observed, facilitating the FDA’s approval of elinzanetant. Dr. Pinkerton expressed optimism that this new therapy will provide relief for women who cannot take hormone therapy and emphasized the importance of individualized patient care.
For further information, refer to the University of Virginia Health System.
