Fezolinetant plain language summary with DOI 23 Apr.pdf (224.09 kB)

Fezolinetant in the treatment of vasomotor symptoms associated with menopause: a profile of its use

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posted on 2024-05-27, 18:27 authored by Hannah A. Blair

Declarations

Funding The preparation of this review was not supported by any external funding.

Authorship and Conflict of interest Hannah A. Blair is a salaried employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to this article and are responsible for its content.

Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability Not applicable.

Additional information about this Adis Drug Review can be found here.

Abstract

Fezolinetant (VEOZAH™; Veoza™), a first-in-class neurokinin 3 receptor (NK3R) antagonist, represents a promising novel non-hormonal treatment option for patients with moderate to severe vasomotor symptoms (VMS) associated with menopause. In randomized, double-blind, multicentre, placebo-controlled, phase 3 trials in menopausal patients born female aged 40–65 years, oral fezolinetant improved the frequency and severity of moderate to severe VMS compared with placebo. These improvements were seen as early as week 1 and were maintained throughout the 12-week double-blind treatment period. The efficacy of fezolinetant was maintained for up to 52 weeks. Fezolinetant was also associated with improvements in sleep disturbance and health-related quality of life. Fezolinetant was generally well tolerated, with the most common adverse event being headache. Serious treatment-emergent adverse events were infrequent. Elevations in liver enzymes were generally asymptomatic, isolated, intermittent or transient, and resolved during or after discontinuation of treatment.