Phase 3 study shows fezolinetant reduces frequency and severity of menopausal hot flashes
Geneviève Neal-Perry, MD, PhD, professor emeritus and chair of obstetrics and gynecology, presented the results of this industry-sponsored study at ENDO 2022, the annual meeting of the Endocrine Society in Atlanta.
In a Phase 3 clinical trial of the drug fezolintant, researchers led by Genevieve Neal-Perry, MD, PhD, professor emeritus and chair of obstetrics and gynecology at the UNC School of Medicine showed that the drug reduced the frequency and severity of moderate ailments considerably. severe vasomotor symptoms (VMS), or hot flushes, associated with menopause.
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
The SKYLIGHT 2 trial was a one-year study to investigate the safety and efficacy of fezolintant, which is a neurokinin 3 receptor antagonist, on the frequency and severity of moderate to severe VMS and disorders some sleep. Mean change in patient-reported sleep disturbance from baseline to week 12 was a key secondary endpoint of the study.
The researchers randomized 501 postmenopausal women aged 40 to 65 with an average of seven or more moderate-to-severe hot flashes/day to placebo or one of two daily doses of fezolinetant – 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-randomised from placebo to fezolintant experienced a reduction in frequency and severity of VMS consistent with women initially 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 selective oral non-hormonal NK3 receptor antagonist to treat moderate to severe VMS associated with menopause,” said Neal-Perry, who presented the research results of this study at ENDO 2022, the annual meeting of the Endocrine Society in mid-June. The study was sponsored by Astellas Pharma Inc. These data have not yet been published in a peer-reviewed journal.
UNC Contact: Mark Derewicz