The first real-world study of the FDA-approved non-hormonal drug fezolinetan finds that the menopause treatment improves hot flashes, depression and anxiety in women, according to an industry-sponsored study to be presented Sunday at ENDO 2026, the Endocrine Society’s annual meeting in Chicago, Illinois.
Hot flashes are a common and bothersome menopause symptom experienced by approximately 80% of women. Both hormonal and non-hormonal treatments are available to women. The study, called OPTION-VMS, is the first real-world study of the effects of these drugs on hot flashes, sleep, and mood. ”
Dr. Pauline M. Maki, Professor of Psychiatry, Psychology, and Obstetrics and Gynecology, University of Illinois at Chicago School of Medicine, Chicago, Illinois;
This portion of the ongoing study included 656 women aged 40 to 75 years with troublesome menopausal vasomotor symptoms who were initially prescribed fezolinetant, SSRI/SNRIs, and non-hormonal medications such as gabapentin and oxybutynin.
The researchers looked at changes from baseline to 12 weeks for bothersome vasomotor symptoms, and from 4, 8, and 12 weeks for depressive and anxiety symptoms.
Women who used fezolinetant (n=201) had significant improvement in hot flashes and/or night sweats from pretreatment to 4, 8, and 12 weeks. Depressive and anxiety symptoms also improved significantly as early as 4 weeks and persisted up to 12 weeks.
“These study results demonstrate that fezolinetant has effects in the real world similar to those seen in clinical trials,” Maki said. “This is important because clinical trials typically have restrictive study enrollment criteria. Study participants are generally healthier than the general population.”
Those receiving SSRI/SNRI (n=329) and other non-hormonal therapy treatments (n=126) also showed improvements in depression and anxiety symptoms from baseline to 4, 8, and 12 weeks.
“The demonstration that non-hormonal therapies are effective in the real world gives women reassurance that there are effective solutions for women’s menopause symptoms, and fesolinetant, an FDA-approved non-hormonal therapy, plays an important role,” Maki said.
