How effective is Veozah in treating vasomotor symptoms?

Veozah(filazonatant)

It is an oral small molecule neurokinin 3 receptor (NK3R) antagonist developed by Astellas Pharma Inc. for the treatment of moderate to severe vasomotor symptoms (VMS) or menopausal hot flashes.

Inhibition of NK3R-mediated signaling in the central nervous system by Veozah (felzonitant) is a non-hormonal strategy to modulate neuronal activity related to thermoregulation, thereby reducing the frequency and severity of VMS.

Fezonatant was first approved in the United States in May 2023 for the treatment of moderate to severe VMS caused by menopause.

Veozah’s efficacy in treating vasomotor symptoms

In a double-blind, placebo-controlled, 12-week Phase 3 trial with an extension of active treatment for 40 weeks, women aged 40 to 65 years with an average of at least 7 moderate-to-severe VMS per day were randomized to 12 weeks of once-daily placebo, 30 mg of fezonem, or 45 mg of fezonem, with completers re-randomized to 30/45 mg of fezonem for 40 weeks.

The primary efficacy endpoint was the mean daily change in VMS frequency and severity from baseline to weeks 4 (W4) and 12 weeks.

Both doses of fellinetan significantly reduced the frequency and severity of VMS at W4 and W12 compared with placebo. For VMS frequency, least squares means (SE) were reduced at W4 compared with placebo, and improvements in VMS frequency and severity were observed at W1 and maintained during W52.

Daily administration of 30 mg or 45 mg of fezonatant is effective and well tolerated in the treatment of moderate to severe VMS associated with menopause.

In another study, a greater proportion of women who received fezonatant met the definition of remission at week 12 compared with placebo. Across all doses, the mean change from baseline in the Menopause-Specific Quality of Life Questionnaire VMS score exceeded MID (1.2) at weeks 4 (placebo: -1.8; felinetan: range, -1.9 to -3.6) and 12 (placebo: -2.3; felinamid: range, -2.9 to -4.4).

The mean changes in the Hot Flashes-Related Daily Interference Scale at Week 4 (placebo: -2.2; felinatam: range, -2.5 to -3.8) and 12 (placebo: -2.9; felinamid: range, -3.3 to -4.3) exceeded the median (1.76).

Greene Menopause Scale-VMS domain scores improved for most doses of nonazonatant compared with placebo (week 4, placebo: -1.7; felinetan: range, -2.1 to -3.3; Week 12, placebo: -2.1; felinetan: range, -2.7 to -3.6).

Oral fezolinetant was associated with higher response rates and greater improvements in quality of life and other PRO measures compared with placebo, including reductions in VMS-related interference with daily life.

Medications for Veozah (Fezolinatant)

It is a 45 mg tablet to be taken orally once daily at approximately the same time each day. It may be taken with or without food. The tablet must be swallowed whole. The tablet must not be cut, crushed or chewed.

References:

1. Johnson KA, Martin N, Nappi RE, Neal-Perry G, Shapiro M, Stute P, Thurston RC, Wolfman W, English M, Franklin C, Lee M, Santoro N. Efficacy and Safety of Fezolinetant in Moderate to Severe Vasomotor Symptoms Associated With Menopause: A Phase 3 RCT. J Clin Endocrinol Metab. 2023 Jul 14;108(8):1981-1997. doi: 10.1210/clinem/dgad058. PMID: 36734148; PMCID: PMC10348473.

2. Santoro N, Waldbaum A, Lederman S, Kroll R, Fraser GL, Lademacher C, Skillern L, Young J, Ramael S. Effect of the neurokinin 3 receptor antagonist fezolinetant on patient-reported outcomes in postmenopausal women with vasomotor symptoms: results of a randomized, placebo-controlled, double-blind, dose-ranging study (VESTA). Menopause. 2020 Dec;27(12):1350-1356. doi: 10.1097/GME.0000000000001621. PMID: 32769757; PMCID: PMC7709922.

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