FDA approves new menopause drug to treat hot flashes and night sweats

The FDA has approved elinzanetant, a new non-hormonal treatment for menopause that reduces hot flushes and night sweats.

Clinical trials in the US, Europe and Israel found the drug significantly reduced both the frequency and severity of hot flushes while improving women’s sleep and quality of life.

The approval follows successful results from the double-blind Oasis trials, led by UVA Health and other international research partners.

The studies enrolled postmenopausal women aged 40 to 65 with moderate to severe hot flushes, randomly assigning them to receive either 120mg of elinzanetant daily for 26 weeks or a placebo for 12 weeks followed by 14 weeks of the drug.

Women who received the treatment reported rapid improvements, with statistically significant reductions in the frequency and intensity of hot flushes within the first week.

By week 12, sleep quality and overall quality of life had also improved across both trials.

JoAnn V. Pinkerton is director of midlife health at UVA Health and US lead for the Oasis II trial.

Pinkerton said: “More than a third of women experience disruptive menopausal symptoms that can persist for more than a decade, significantly impacting work, home and quality of life.

“Many symptomatic menopausal women continue to suffer without treatment and support.

“With the FDA approval of elinzanetant, women will have access to a new, safe and effective therapy for relief of hot flushes and night sweats.

“Due to its dual receptor antagonism, the studies also showed improvements in sleep and mood.”

Hot flushes are caused by a drop in oestrogen levels during menopause, which affects how the brain regulates body temperature.

Hormone therapy remains the most effective treatment, but it can cause side effects such as breast tenderness, bloating, headaches or spotting.

In rare cases, long-term hormone use, particularly oral therapy, can raise the risk of blood clots, strokes or certain cancers such as uterine cancer if oestrogen is used without a uterine antagonist — a drug that blocks its effects on the womb.

Some women cannot take hormone therapy due to contraindications such as a history of blood clots or oestrogen-sensitive cancers.

Elinzanetant works through dual receptor antagonism, blocking two receptors involved in temperature regulation and other menopausal symptoms.

The most common side effects seen in the trials were mild headache and fatigue. No serious side effects were reported.

Pinkerton said: “I am excited that women who can’t or choose not to take hormone therapy will have access to elinzanetant, which is an effective and tested, FDA-approved therapy for bothersome symptoms.

“It’s critical that we listen to our patients to understand exactly what they are experiencing and then help them get the support they need, tailored to their individual needs.”