Is Veozah (felzonitant) effective in treating vasomotor symptoms caused by menopause?

Veozah (felzonitant) is effective in treating vasomotor syndrome (VMS) caused by menopause and can significantly improve the symptoms of hot flashes. In clinical studies, women treated with Veozah experienced significant reductions in the frequency and severity of vasomotor symptoms after four and 12 weeks, while improving health-related quality of life.

Veozah(filazonatant)

It is the first antibody to the neurohormone receptor 3 (NK3) approved by the FDA for the treatment of moderate to severe menopausal hot flashes. It works by attaching to and blocking the activity of the NK3 receptor, which has an impact on regulating the brain's body temperature.

Veozah reduces the frequency and intensity of hot flashes in women by targeting the temperature control center of the brain, modulating neural activity in the brain's temperature regulation center (hypothalamus) by blocking the binding of neurokinin B (NKB) to the central nervous system/neurokinin B/dynorphin (KNDy) nerve, thereby reducing the frequency and severity of moderate to severe VMS.

Clinical study of Veozah (felzonitant) in the treatment of vasomotor syndrome caused by menopause

Menopausal women aged >40-65 years with moderate/severe vasomotor symptoms (≥50 episodes/week) were randomized (double-blind) to receive fezonatant 15, 30, 60, 90 mg BID or 30, 60, 120 mg QD or placebo for 12 weeks.

Of the 352 treated participants, 287 completed the study, fezonatant reduced moderate/severe VMS frequency by -1.9 to -3.5/day at week 4 and -1.8 to -2.6/day at week 12. The mean difference in VMS severity scores versus placebo at weeks 4 and 12 was -0.4 to -1.

At the end of treatment, responses (50% reduction) ranged from 81.4% to 94.7% compared to placebo in 58.5% of participants. Treatment-emergent adverse events were mostly mild/moderate and no serious treatment-related treatment-emergent adverse events occurred.

At week 12, fezonetant significantly reduced total VMS score compared with placebo (-26.5 vs -12.2, P < 0.001) and reduced the mean frequency of moderate/severe VMS by 5 times/day compared with placebo. From the first day of treatment, the severity and frequency of moderate/severe VMSs decreased, and all quality-of-life measures improved.

Fezonatant is a well-tolerated and effective non-hormonal therapy that rapidly reduces moderate/severe postmenopausal vasomotor symptoms.

of Veozah (felzonitant)

Baseline blood tests to evaluate liver function and liver injury should be performed before starting treatment with Veozah (felzonitant). Veozah is taken once daily as one 45mg tablet, with or without food.

Blood tests are required at 3, 6 and 9 months after starting treatment and when symptoms suggestive of liver damage appear.

References:

Fraser GL, Lederman S, Waldbaum A, Kroll R, Santoro N, Lee M, Skillern L, Ramael S. A phase 2b, randomized, placebo-controlled, double-blind, dose-ranging study of the neurokinin 3 receptor antagonist fezolinetant for vasomotor symptoms associated with menopause. Menopause. 2020 Apr;27(4):382-392. doi: 10.1097/GME.0000000000001510. PMID: 32102086; PMCID: PMC7147405.

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