Fezolinetant was efficacious with or without concurrent use of selective serotonin reuptake inhibitors (SSRIs) in a pooled analysis of the Phase 3 trials SKYLIGHT 1 and 2, but no safety subgroup analysis was conducted. Fezolinetant is contraindicated in individuals using CYP1A2 inhibitors
The number of participants with baseline data ia shown.
P values were calculated without multiplicity adjustment.
aFAS: All randomized participants assessed according to the randomization at first dose. Total numbers of participants – placebo: 342, fezolinetant 30 mg: 339, fezolinetant 45 mg: 341.
Adapted from: Santoro NF, Menopause 2024.
Figure 2. Difference in change from baseline to Week 12 in VMS severity between fezolinetant groups and placebo by concurrent use of SSRIs.4
The number of participants with baseline data is shown.
P values were calculated without multiplicity adjustment.
aFAS: All randomized participants assessed according to the randomization at first dose. Total numbers of participants – placebo: 342, fezolinetant 30 mg: 339, fezolinetant 45 mg: 341.
Adapted from: Santoro NF, Menopause 2024.
VEOZAH [package insert]. Northbrook, IL, USA: Astellas Pharma, Inc. Available at: https://www.astellas.com/us/system/files/veozah_uspi.pdf.
Lexicomp Online. Inhibitors and Inducers of Cytochrome P450 Enzymes (Lexi-Drugs). Available at: https://online.lexi.com/lco/action/home.
Data on file.
Santoro N, Nappi R, Neal-Perry G, et al. Fezolinetant treatment of moderate-to-severe vasomotor symptoms due to menopause: Effect of intrinsic and extrinsic factors in two phase 3 studies (SKYLIGHT 1 and 2). Menopause. 2024;31(4):247-257. Available at: https://dx.doi.org/10.1097/gme.0000000000002340.
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