Non-hormonal drug treats hot flashes in menopausal women

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, according to international research led by The University of Virginia (UVA) and published in JAMA.

Hot flashes are caused by decreased oestrogen levels during menopause and, for some women, for years after. While there are existing treatment options, such as hormone therapy, some women cannot tolerate them or do not wish to take them because of potential side effects or contraindications. Because of this, menopausal women need a new, effective and safe non-oestrogen alternative.

“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 Professor JoAnn V Pinkerton, UVA Health’s Director of Midlife Health 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.”

Seeking a new alternative for women struggling with hot flashes, Pinkerton and her colleagues tested the non-hormonal drug elinzanetant, which contains no oestrogen, in two double-blinded phase 3 trials, Oasis 1 and 2, at dozens of locations in the United States, Europe and Israel, including UVA Health. Postmenopausal women aged 40–65 with moderate to severe hot flashes were randomised to receive either 120 mg of elinzanetant daily for 26 weeks or a harmless matching placebo for 12 weeks followed by 14 weeks on elinzanetant.

“Elinzanetant is a dual neurokinin receptor antagonist in testing, meaning it works on two receptors in the brain to improve hot flashes, night sweats, sleep and overall mood,” Pinkerton explained.

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 quality and overall quality of life improved in both trials by week 12. The most common side effects included headaches and fatigue, but these were mild in severity.

“The effectiveness for relief of hot flashes in highly symptomatic women, along with improvements in sleep and mood across multiple trials and favourable safety profile of elinzanetant, suggests it has potential as a non-estrogen treatment for women with bothersome menopausal symptoms,” Pinkerton said.

“I am excited about the potential of elinzanetant to serve as a non-hormonal treatment option for women with highly bothersome menopausal symptoms who can’t or won’t take hormone therapy,” she continued. “I hope that it may become a safe and effective non-oestrogen option for menopausal women suffering from the triad of moderate to severe VMS, sleep disruption and decreased menopause-related quality of life.”

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