Research & Discovery

Hot Flash Drug Shows Significant, Rapid Benefits in Pivotal Clinical Trials

August 22, 2024 • By Josh Barney, jdb9a@virginia.edu Josh Barney, jdb9a@virginia.edu

Elinzanetant, an investigational drug, is showing promise for the treatment of hot flashes after two major trials were conducted in Europe, Israel and in the United States, including at UVA Health. (Illustration by Alex Angelich, University Communications)

The investigational drug elinzanetant significantly reduces the frequency and severity of hot flashes associated with menopause, while improving women’s sleep and quality of life, new UVA Health research published in the prestigious Journal of the American Medical Association shows.

The nonhormonal drug, which contains no estrogen, was tested in two major trials, Oasis 1 and Oasis 2, at dozens of locations in Europe, Israel and the United States including UVA Health. In the trials, postmenopausal women between the ages of 40 and 65 who experience moderate to severe hot flashes were randomly assigned to receive elinzanetant daily for 26 weeks or a harmless placebo for 12 weeks followed by 14 weeks of elinzanetant.

The women who received elinzanetant reported rapid improvements in their symptoms and quality of life. The trials revealed statistically significant reductions in hot flash frequency and severity within the first week in both trials. At the same time, sleep and overall quality of life improved in both trials by week 12.

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“The effectiveness for relief of hot flashes in highly symptomatic women, along with improvements in sleep and mood across multiple trials and favorable safety profile of elinzanetant, suggests it has potential as a non-estrogen treatment for women with bothersome menopausal symptoms,” researcher Dr. JoAnn V. Pinkerton, UVA Health’s director of midlife health, said.

Hot Flash Treatment

Decreased estrogen levels during menopause – and for some women, for years afterward – cause hot flashes. While hormone therapy is an existing treatment option, some women cannot tolerate it or prefer not to use it due to potential side effects or contraindications. Because of that, researchers say, menopausal women need a new, effective and safe non-estrogen alternative.

Researcher Dr. JoAnn V. Pinkerton, UVA Health’s director of midlife health, is “excited about the potential of elinzanetant to serve as a nonhormonal treatment option.” (UVA Health photo)

“There is a huge unmet need for new treatments for burdensome hot flashes and sweats, which have been shown to affect workplace productivity and relationships, both at work and home,” said Pinkerton, professor of obstetrics and gynecology at the University of Virginia School of Medicine and executive director emeritus of The Menopause Society. “Sleep disturbances are one of the most bothersome symptoms reported by menopausal women and can impact mood, fatigue, emotional lability, work productivity and their quality of life.”

In addition to evaluating elinzanetant’s effect on hot flashes, sleep disruptions and quality of life, researchers also looked for potential side effects. Headaches and fatigue were the most common side effects, but they were mild. No severe side effects were reported, which is reassuring for the drug's safety.

“I am excited about the potential of elinzanetant to serve as a nonhormonal treatment option for women with highly bothersome menopausal symptoms who can’t or won’t take hormone therapy,” Pinkerton said. “I hope that it may become a safe and effective non-estrogen option for menopausal women.”

The Oasis trials were funded by Bayer.