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, MD, PhD, 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 30mg or 45mg for 12 weeks, after which they entered a 40-week extension phase where those on placebo were randomly assigned to fezolinetant 30mg or 45mg. Data were included for 484 women (166 received fezolinetant 30mg, 167 fezolinetant 45mg, 76 placebo/fezolinetant 30mg, and 75 placebo/fezolinetant 45mg).
The researchers observed a statistically significant improvement in VMS frequency and severity with fezolinetant vs 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 30mg and 45mg, 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 30mg and 45mg, 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.