CHICAGO—The first real-world study of the FDA-approved non-hormone treatment fezolinetant found the menopausal medication improved hot flashes, depression and anxiety in women, according to industry-sponsored research being presented Sunday at ENDO 2026, the Endocrine Society's annual meeting in Chicago, Ill.
"Hot flashes are a common and bothersome symptom of menopause experienced by about 80% of women. Both hormonal and non-hormonal treatments are available to women," said Pauline M. Maki, Ph.D., professor of psychiatry, psychology and OB/GYN at the University of Illinois Chicago College of Medicine in Chicago, Ill. "This study, called OPTION-VMS, is the first real-world study of the effect of these medications on hot flashes, sleep and mood."
This portion of the ongoing study included 656 women ages 40 to 75 with bothersome menopausal vasomotor symptoms who were first prescribed a non-hormone therapy drug, such as fezolinetant, SSRIs/SNRIs, and others, like gabapentin and oxybutynin.
The researchers checked for changes from baseline to 12 weeks for bothersome vasomotor symptoms and 4, 8 and 12 weeks for depressive and anxiety symptoms.
In women using fezolinetant (n=201), hot flashes and/or night sweats significantly improved from pre-treatment to 4, 8 and 12 weeks. Depressive and anxiety symptoms were also significantly improved as early as 4 weeks and continued through 12 weeks.
"These findings show that in the real world, fezolinetant shows benefits similar to what was seen in clinical trials," Maki said. "That's important because clinical trials generally have restrictive criteria for study enrollment. Study participants are generally healthier than the general population."
Those taking SSRIs/SNRIs (n=329) and other non-hormone therapy treatments (n=126) also saw improvements in their depressive and anxiety symptoms from baseline to 4, 8 and 12 weeks.
"The demonstration that non-hormonal treatments are effective in the real world provides women with reassurance that there are solutions for women's menopause symptoms that work and that fezolinetant, as an FDA-approved non-hormonal treatment, plays an important role," Maki said.
