Hot flash medication shows significant benefits in clinical trials

New research shows that the investigational drug elinzanetant significantly reduces the frequency and severity of hot flashes associated with menopause while improving women's quality of life.

The non-hormonal drug, which does not contain estrogen, has been tested in two Phase 3 trials, Oasis 1 and 2, at dozens of sites in the United States, Europe and Israel, including at UVA Health.

Postmenopausal women aged 40 to 65 years with moderate to severe hot flashes were randomly assigned to receive either 120 mg of elinzanetant daily for 26 weeks or a harmless matching placebo for 12 weeks followed by elinzanetant for 14 weeks.

The women who received elinzanetant reported rapid improvement in their symptoms and quality of life. The studies showed a statistically significant reduction in the frequency and severity of hot flashes within the first week in both studies. At the same time, sleep quality and overall quality of life improved in both studies up to week 12.

The results are published in Journal of the American Medical Association.

“The efficacy of elinzanetant in relieving hot flashes in women with severe symptoms, as well as improvements in sleep and mood in several studies and its favorable safety profile, suggest that it may be appropriate as a non-estrogenic treatment for women with bothersome menopausal symptoms,” said researcher JoAnn V. Pinkerton, MD, director of midlife health at UVA Health.

“Elinzenetant is an investigational dual neurokinin receptor antagonist, meaning it acts on two receptors in the brain to improve hot flashes, night sweats, sleep and overall mood.”

Treatment of hot flashes

Hot flashes are caused by reduced estrogen levels during menopause and, in some women, for years afterward. While treatment options such as hormone therapy exist, some women cannot tolerate them or do not want to take them due to potential side effects or contraindications. For this reason, the researchers say, there is a need for a new, effective, non-hormonal alternative.

“There is a tremendous unmet need for new treatments for hot flashes. Menopausal women who cannot or choose not to take hormone therapy for health reasons need more non-estrogen-containing alternatives to relieve their annoying hot flashes and sweats, which have been shown to impact workplace productivity and relationships both at work and at home,” said Pinkerton, professor of obstetrics and gynecology at the University of Virginia School of Medicine and executive director emeritus of the North American Menopause Society.

“Sleep disturbances are among the most distressing symptoms reported by women during menopause and can impact mood, emotional instability, work productivity and quality of life.”

Pinkerton and her colleagues tested elinzanetant in the double-blind Oasis trials to see if it could be a safe and effective new alternative for women with hot flashes. (“Double-blind” means that neither the study participants nor the researchers knew whether each participant was receiving the drug or a placebo until the study was over.)

In addition to evaluating the drug's effect on hot flashes, sleep disturbances and quality of life, researchers also looked at potential side effects. Headaches and fatigue were the most common, and these were mild. Importantly, there were no serious side effects, which is reassuring about the drug's safety.

“I am excited about the potential of elinzanetant as a non-hormonal treatment option for women with extremely distressing menopausal symptoms who cannot or do not want to take hormone therapy,” said Pinkerton.

“I hope it can become a safe and effective estrogen-free alternative for menopausal women suffering from the triad of moderate to severe VMS, sleep disturbances and reduced menopausal-related quality of life.