ENDO: Fezolinetant Cuts Vasomotor Symptoms in Menopause
Frequency and severity of vasomotor symptoms reduced with fezolinetant versus placebo through 12 weeks
TUESDAY, June 14, 2022 (HealthDay News) -- Fezolinetant reduces the frequency and severity of moderate-to-severe vasomotor symptoms (VMS) associated with menopause, according to a study presented at the annual meeting of the Endocrine Society, held from June 11 to 14 in Atlanta.
Genevieve Neal-Perry, M.D., Ph.D., from the University of North Carolina School of Medicine in Chapel Hill, and colleagues randomly assigned women aged ≥40 to 65 years with moderate-to-severe VMS associated with menopause to once-daily placebo or fezolinetant 30 mg or 45 mg for 12 weeks, after which they entered a 40-week extension phase where those on placebo were randomly assigned to fezolinetant 30 mg or 45 mg. Data were included for 484 women (166 received fezolinetant 30 mg, 167 fezolinetant 45 mg, 76 placebo/fezolinetant 30 mg, and 75 placebo/fezolinetant 45 mg).
The researchers observed a statistically significant improvement in VMS frequency and severity with fezolinetant versus placebo through week 12, which was maintained through 52 weeks. There was a least squares (LS) mean baseline-to-week-12 reduction of −6.83 and −7.50 VMS/day for fezolinetant 30 mg and 45 mg, respectively, for VMS frequency; the corresponding mean baseline-to-week-52 reductions were −8.03 and −8.48. The LS mean baseline-to-week-12 reduction for VMS severity was −0.64 and −0.77 for fezolinetant 30 mg and 45 mg, respectively; the corresponding mean baseline-to-week-52 reductions were −0.83 and −0.95.
"These results, along with other fezolinetant studies, will be important in understanding the use of this oral nonhormonal selective NK3 receptor antagonist to treat moderate-to-severe VMS associated with menopause," Neal-Perry said in a statement.
The study was funded by Astellas Pharma, the manufacturer of fezolinetant.