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Hot flush frequency, severity diminish with NK3R antagonist

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Julia K. Prague

PHILADELPHIA — Neurokinin-3 receptor antagonism — an experimental therapy exploiting an important mediator in hot flushes — may prove to be an effective alternative to hormone therapy for women with this common menopausal symptom, according to data presented at the Annual Meeting of the North American Menopause Society.

“What will be most surprising to the audience will be the speed of action of the antagonist; ie, how effective it was and how quickly that effect occurred,” Julia K. Prague, MBBS, an MRC clinical research fellow at Imperial College London, told Endocrine Today.

In a phase 2, randomized, double-blind, placebo-controlled crossover trial, Prague and colleagues recruited 68 women between February and October 2016 to assess the effectiveness of MLE4901 (Millendo Therapeutics), an oral neurokinin-3 receptor (NK3R) antagonist, for relieving hot flushes. The women were aged 49 to 62 years and reported experiencing at least seven hot flushes each day, some of which they considered to be bothersome or severe. Researchers assigned 37 of the women to MLE4901 or placebo for 4 weeks and then the reverse, in random order, after a 2-week washout period.

In the treatment group, the total weekly number of hot flushes dropped by 73% compared with baseline (P < .0001; 45-percentage-point decrease vs. placebo in week 4).

In post-hoc time-course analysis in a modified intent-to-treat population (minimum n = 34), researchers found that frequency of hot flushes among the treatment group diminished by 72% compared with baseline as early as day 3 (P < .0001; 51-percentage-point decrease vs. placebo) and was maintained throughout the study period (P < .0001). Severity of hot flushes was also reduced in the treatment group after day 3 — by 38% compared with baseline (P < .001; 31-percentage-point decrease vs. placebo); hot flush bother and interference declined as well — bother by 39% compared with baseline (P < .0001; 34-percentage-point decrease vs. placebo) and interference by 61% compared with baseline (P = .0006; 37-percentage-point decrease vs. placebo). All three parameters continued to improve during the treatment period.

Participants also reported improved sleep as early as day 3 of treatment with MLE4901 compared with placebo, according to the researchers.

“The main take-away message is one of hope; a new targeted therapeutic could change the way that we treat hot flushes in the future, bringing relief to so many millions of women worldwide,” Prague said. – by Jill Rollet

Reference:

Prague J, et al. Abstract S-14. Presented at: Annual Meeting of the North American Menopause Society; Oct. 11-14, 2017; Philadelphia.

Disclosures: The UK Medical Research Council and the National Institute for Health Research funded this study. Prague reports no relevant financial disclosures.