2023: New Hot Flash Treatment

On This Day in Health: May 12, 2023

On May 12, 2023, the U.S. Food and Drug Administration approved fezolinetant, sold as Veozah, to treat moderate to severe hot flashes associated with menopause. The medicine introduced a new nonhormonal approach by blocking the neurokinin 3 receptor, a component of the brain's temperature-regulating system. The decision addressed symptoms that can disrupt sleep, daily activities and quality of life. It was a significant addition to treatment choices because it acted through a different pathway from hormone therapy. The approval did not mean that every menopausal symptom could be treated by the new medicine or that it suited every patient.

Hot flashes involve changes in the body's regulation of temperature during the menopausal transition. Fezolinetant targets signaling involving neurokinin B rather than replacing estrogen. That distinction made the mechanism noteworthy, particularly in a field where personal circumstances can limit the use of hormonal treatments. The approved product was an oral tablet taken once daily. Its purpose was to reduce the frequency and severity of vasomotor symptoms, not to reverse menopause itself. A new mechanism could broaden options, but choosing among them still required consideration of medical history, other medicines, symptom burden and the balance between expected benefit and potential harm.

The FDA reviewed evidence from three clinical trials involving 2,859 participants, with two trials providing the principal efficacy assessment. Participants in those studies experienced frequent moderate or severe hot flashes, and researchers compared changes in symptoms with placebo. The evaluation included longer-term safety information as well as symptom measurements. Approval was followed by continuing surveillance, which later produced an important change in the safety information. In December 2024, the FDA added a boxed warning about rare but serious liver injury. Liver testing before and during treatment became central to the safety requirements. That later warning belongs in the history of the product, even though it was not part of the original approval announcement.

May 12 is therefore an anniversary of both therapeutic innovation and the limits of what an initial decision can establish. A medicine can provide a useful new option while still requiring its risks to be reassessed as more people receive it. The distinction between a trial population and wider clinical use is especially important when uncommon adverse effects emerge after marketing. The 2023 approval expanded the ways clinicians could address a substantial menopausal symptom burden, while subsequent experience reinforced the need for monitoring and clear patient information. Remembering the milestone accurately means recording the original advance alongside later evidence, rather than presenting the anniversary as an uncomplicated endorsement of treatment.