Fezolinetant significantly reduced the frequency and severity of moderate-to-severe vasomotor symptoms (VMS), or hot flashes, associated with menopause, according to an industry-sponsored phase 3 study presented Saturday at ENDO 2022, the annual meeting of the Endocrine Society in Atlanta, Ga.
The SKYLIGHT 2 trial was a 52-week study to investigate the safety and efficacy of fezolintant (a neurokinin 3 receptor antagonist) on the frequency and severity of moderate to severe VMS and sleep disturbances. Mean change in patient-reported sleep disturbance from baseline to week 12 was a key secondary endpoint of the study.
VMS associated with menopause, which is characterized by hot flashes and/or night sweats, affects millions of women worldwide and can impact daily activities and quality of life.”
Geneviève Neal-Perry, MD, Ph.D., professor emeritus and chair of obstetrics and gynecology at the University of North Carolina School of Medicine in Chapel Hill, North Carolina
The phase 3 double-blind study randomized 501 postmenopausal women aged 40-65 with an average of seven or more moderate to severe hot flashes/day to placebo or one of two daily doses of fezolintant- ; 30 mg or 45 mg -; for 12 weeks. During the extension period, those on placebo were re-randomised to receive fezolintant 30 mg or 45 mg, and those initially on fezolintant remained on their dose for the remaining 40 weeks. The extension period analysis included 484 women.
Neal-Perry and colleagues assessed the efficacy of fezolintant versus placebo and found improvement in VMS frequency and severity through week 12. Both doses were associated with a statistically significant reduction in frequency and severity of hot flashes, which was maintained throughout the 52-week study period. The data supports the overall safety and tolerability previously observed for fezolinetant at doses of 30 and 45 mg.
Those who were re-randomized from placebo to fezolintant experienced a reduction in frequency and severity of VMS consistent with women originally randomized to fezolintant. Treatment also reduced sleep disturbance, as assessed by the Patient-Reported Outcome Measurement Information System (PROMIS SD SF 8b).
“These results, along with other studies of fezolintant, will be important in understanding the use of this oral, non-hormonal, selective NK3 receptor antagonist to treat moderate to severe VMS associated with menopause,” Neal-Perry said.
The study was sponsored by Astellas Pharma Inc.
Neal-Perry will speak at the Endocrine Society’s Reproductive Health Press Conference on Monday, June 13 at 9 a.m. Register to watch the press conference at www.endowebcasting.com.