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Update on Non-Hormonal Agent Improving Sleep, and Mood in Post-Menopausal Women

12 October 2020

A previous News item "New non hormonal treatment in development for flushes" explained the role of a chemical pathway involving neurokinin B/ neurokinin-3-receptor (NKB/NK3R) in the development of hot flushes, interacting with the temperature controlling centre in the brain.
Neurokinin B binds to the neurokinin-3-receptor to stimulate its effects. In postmenopausal women, estrogen deficiency increases neurokinin B so that the pathway is overstimulated, leading to flushes and sweats. Therefore, agents which act against neurokinin-3-receptor (NK3R antagonists) could suppress the pathway and reduce flushes and sweats. One such antagonist, NT-814 showed promising results in reducing hot flushes.

From a study presented at the 2020 Virtual Meeting of the North American Menopause Society (NAMS), NT-814, has now been shown to significantly improve sleep, mood, and quality of life in post-menopausal women.
In SWITCH-1 199 post-menopausal women aged 40 to 65 years with hot flushes were randomised in a double-blinded fashion to receive placebo or NT-814 40 mg, 80 mg, 120 mg, or 160 mg for 12 weeks, following a 2-week single-blind placebo run-in.

Improvements in all patient-reported outcome assessments were significant (P< .05) for the 120 mg and 160 mg doses at weeks 4 and 12, with no difference from placebo for the 40mg and 80mg doses.

There were no serious adverse events related to treatment.

"These data demonstrate the potential for the dual NK1 receptor and NK3 receptor antagonism of NT-814 to provide broad benefit on well-being beyond improving hot flashes in post-menopausal women," the authors concluded.

Funding for this study was provided by KaNDy Therapeutics Ltd.

[Presentation title: NT-814, a Non-Hormonal Dual NK1,3 Receptor Antagonist Markedly Improves Sleep, Mood and Quality of Life in Post-Menopausal Women. Results of a Randomised, Double-Blind, Placebo-Controlled Study (SWITCH-1). Abstract S-9]

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