NT-814 shows therapeutic potential in postmenopausal women with hot flashes
Treatment with the dual neurokinin 1,3 antagonist NT-814 induces prompt, marked improvements in hot flashes and waking due to night sweats in postmenopausal women, with doses up to 300 mg being well tolerated, according to the results of a trial.
The trial randomized 76 postmenopausal women with moderate/severe hot flashes to receive 14 days of once-daily NT-814 (at 50, 100, 150 or 300 mg) or placebo. All women completed diaries of hot flash frequency and severity, as well as of waking due to night sweats, at baseline and during treatment.
All prespecified efficacy parameters (24-hour hot flash frequency and severity, frequency of waking due to night sweats) improved in all groups, even in placebo. At week 2, moderate/severe hot flash frequency decreased by a mean of 37 percent with placebo vs 24 percent with 50-mg (p=0.048), 59 percent with 100-mg (p=0.155), 84 percent with 150-mg (p<0.001) and 66 percent with 300-mg (p=0.022) NT-814.
Furthermore, the number of episodes of waking due to night sweats dropped by 32 percent in the placebo group vs 20 percent (p=0.059), 55 percent (p=0.135), 81 percent (p<0.001) and 63 percent (p=0.031) in the respective NT-814 dose-groups (50, 100,150 and 300 mg).
The improvements with NT-814 ≥150 mg occurred as early as the first week of treatment. Commonly reported treatment-related adverse events were mild somnolence and headache, observed frequently in the 300-mg group. Safety monitoring identified no concerns.