The selective neurokinin 3 receptor antagonistGraeme L. Fraser, PhD, of Ogeda, a subsidiary of Astellas Pharma, and associates reported in .
The investigators conducted a randomized, double-blind, placebo-controlled, dose-ranging, parallel-group study between July 19, 2017, and Sept. 19, 2018, in 287 women who completed the full 12-week trial. The women were aged between 41 and 65 years, were menopausal, and had moderate to severe vasomotor symptoms (VMS) with an incidence of at least 50 episodes per week. The majority of the women were white, 25% were black, 1% were Asian, and 1% were “other.”
The reduction in VMS episodes in patients who received fezolinetant ranged from 1.9 to 3.5 episodes per day at week 4 and from 1.8 to 2.6 per day at week 12. The mean difference from placebo in VMS severity score was –0.4 to –1 at week 4 and was –0.2 to –0.6 at week 12. At least a 50% reduction in VMS frequency at week 12 was achieved by 81%-95% of patients who received fezolinetant, compared with 59% of those who received placebo.
Treatment-emergent adverse events were generally mild to moderate, with the most common events including nausea, diarrhea, fatigue, urinary tract infection, upper respiratory tract infections, sinusitis, headache, and cough. Of the five severe adverse events reported, only two were considered related to treatment – cholelithiasis and drug-induced liver injury. A total of 21 patients discontinued because of adverse events.
“Further evaluation of fezolinetant in larger and longer phase 3 trials of women with VMS associated with menopause is warranted to more fully characterize its efficacy and safety profile,” Dr. Fraser and colleagues concluded.
The study was funded by Astellas Pharma. The investigators reported numerous conflicts of interest with pharmaceutical companies.
SOURCE: Fraser GL et al.