HomeLifestyleHealth & FitnessA Nonhormonal Therapy Reduced Symptoms Of Menopause In Phase 3 Trial

A Nonhormonal Therapy Reduced Symptoms Of Menopause In Phase 3 Trial

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A Phase 3 study found that Fezolinetant decreased the frequency and severity of moderate-to-severe vasomotor symptoms (VMS), or hot flashes, caused by menopause.

The SKYLIGHT 2 experiment was 52-week research to see if fezolinetant (a neurokinin 3 receptor antagonist) may reduce the incidence and severity of moderate-to-severe VMS and sleep disturbance. A key secondary goal in the trial was the mean change in patient-reported sleep disruption from baseline to week 12.

“VMS associated with menopause, which are characterized by hot flashes and/or night sweats, affect millions of women worldwide and can impact daily activities and quality of life,” explained professor Genevieve Neal-Perry from the University of North Carolina School of Medicine.

For 12 weeks, 501 postmenopausal women ages 40–65 with an average of seven or more moderate-to-severe hot flashes per day were exposed to placebo or one of two once-daily dosages of fezolinetant—30mg or 45mg—in a double-blind Phase 3 research. Those on placebo were re-randomized to fezolinetant 30mg or 45mg during the extension phase, while those on fezolinetant were kept on their dose for the remaining 40 weeks. There were 484 women in the extension period study.

Through week 12, Neal-Perry and colleagues found improvement in VMS frequency and intensity when fezolinetant was compared to placebo. Both doses were linked to a statistically significant decrease in the frequency and intensity of hot flashes, which was sustained over the course of the 52-week research. The results back up the general safety and tolerability of fezolinetant at the 30 and 45 mg doses.

Women who were re-randomized from placebo to fezolinetant showed a reduction in the incidence and severity of VMS, similar to those who had been randomized to fezolinetant initially. According to the Patient-Reported Outcomes Measurement Information System Sleep Disturbance (PROMIS SD SF 8b), the therapy also reduced sleep disruptions.

“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 remarked.

Image Credit: Getty

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