“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,” said Pinkerton, the U.S. lead for the Oasis II clinical trial that tested the drug. “With the FDA approval of elinzanetant, women will have access to a new, safe and effective therapy for relief of hot flashes and night sweats. Due to its dual receptor antagonism, the studies also showed improvements in sleep and mood.”
Hot Flashes and Other Menopause Symptoms
Hot flashes are caused by decreased estrogen levels during menopause and, for some women, years after. Hormone therapy is the most effective treatment for menopause symptoms, but this can come with side effects – usually minor – such as breast tenderness, bloating, headaches or spotting. Less commonly, long-term hormone therapy, particularly oral therapy, can increase the risk of blood clots or strokes or up the risk of certain cancers such as uterine cancer if estrogen is used by itself without a uterine antagonist. There are also contraindications, such as having a prior history of blood clots or estrogen sensitive cancers, that prevent women from being able to take the treatment.
Pinkerton and colleagues across the United States, Europe and Israel tested elinzanetant in the double-blinded Oasis trials to see if it could offer a new alternative. They enrolled postmenopausal women ages 40-65 with moderate to severe hot flashes, randomizing them to receive either 120 mg of elinzanetant daily for 26 weeks or a placebo for 12 weeks followed by 14 weeks of elinzanetant.
Trial Results
The women who received elinzanetant reported rapid improvements in their symptoms and quality of life. Both trials revealed statistically significant reductions in hot flash frequency and severity within the first week. At the same time, sleep quality and overall quality of life improved in both trials by week 12.
In addition to evaluating the drug's effect on hot flashes and sleep disruptions, the researchers also looked for potential side effects. Headache and fatigue were the most common, but these were mild. There were no severe side effects, paving the way for FDA approval of the drug.
“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,” said Pinkerton, of the UVA School of Medicine. “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.”
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.