How fezolinetant revolutionizes non-hormonal menopause therapy

In an interview with Contemporary OB/GYN, Marla Shapiro, a professor at the University of Toronto and specialist in preventive medicine and public health, discussed the results of studies on fezolinetant, a treatment for menopause-related symptoms such as hot flashes and sleep disturbances.

The research focused on 2 clinical trials, SKYLIGHT 1 and SKYLIGHT 2, involving approximately 1,000 participants. Participants were divided into 3 groups: receiving either placebo, 30 mg fezolinetant, or 45 mg fezolinetant. After 4 weeks, participants in the placebo group were re-randomized to receive either 30 or 45 mg of fezolinetant.

The ability to fall and stay asleep and daytime functioning after sleep were the primary sleep functions evaluated. Both participants who initially had sleep issues and those who did not experienced improvements in sleep quality and next-day functioning when taking fezolinetant, especially at the 45 mg dose. The medication proved more effective than the placebo, with marked improvements by week 12, especially among those with initial sleep problems.

A key breakthrough from the study was the understanding of the biological mechanism behind hot flashes, which occur because of an imbalance between estrogen and neurokinin-3 in the brain. By acting as a neurokinin-3 receptor antagonist, fezolinetant helps reduce hot flashes and night sweats, providing relief for women experiencing these symptoms during menopause.

The significance of fezolinetant lies in its being the first on-label, non-hormonal treatment option for menopausal symptoms supported by large, randomized clinical trial data. Until now, treatment options were either off-label or based on hormone therapy, which some women may avoid because of personal or medical reasons. Shapiro noted that while menopausal hormone therapy remains the gold standard for many, fezolinetant offers a critical alternative for women who prefer non-hormonal solutions. The advent of this treatment not only advances scientific understanding of menopause but also broadens the options available to women, allowing them to make informed decisions about managing their symptoms.