Non-hormone medication addresses menopausal symptoms in women

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.

About the Endocrine Society
Endocrinologists are at the core of solving the most pressing health problems of our time, including diabetes, obesity, infertility, bone health, and hormone-related cancers. The Endocrine Society is the largest global organization of scientists devoted to hormone research and physicians who care for people with hormone-related conditions.

With more than 18,000 members in 133 countries, the Society serves as the voice of the endocrine field. Through its renowned journals and ENDO, the world's largest endocrine meeting, the Society accelerates hormone research, advances clinical excellence in endocrinology, and advocates for evidence-based policies on behalf of  the global endocrine community. To learn more, visit our online newsroom.