Non-Hormonal Agent Improves Sleep, Mood in Post-Menopausal Women: Presented at NAMS

By Eric Ramos

CHICAGO -- October 2, 2020 -- NT-814, a non-hormonal dual neurokinin (NK) 1 and 3 receptor antagonist, significantly improved sleep, mood, and quality of life in post-menopausal women, according to a study presented at the 2020 Virtual Meeting of the North American Menopause Society (NAMS).

SWITCH-1 randomised 199 post-menopausal women aged 40 to 65 years with hot flashes in a double-blinded fashion to receive placebo (n = 47) or NT-814 40 mg (n = 31), 80 mg (n = 17), 120 mg (n = 52), or 160 mg (n = 52) for 12 weeks, following a 2-week single-blind placebo run-in.

“Dose-related improvement in mean scores for all patient-reported outcome assessments were observed with NT-814 at weeks, 4, 8, and 12, with a similar magnitude of effect at the 120 and 160 mg doses,” stated Hadine Joffe, MD, Brigham & Women’s Hospital, Boston, Massachusetts.

Improvements in all patient-reported outcome assessments -- the Insomnia Severity Index (ISI), the Beck Depression Inventory (BDI) II, and the Menopause-Specific Quality of Life Questionnaire (MenQOL) -- were significant (P

“The 40 mg and 80 mg doses were not consistently significantly different versus placebo,” said Dr. Joffe.

For the ISI, the mean change from baseline to week 12 was -2.13 for placebo, -3.60 for NT-814 40 mg, -5.91 for NT-814 80 mg, -6.41 for NT-814 120 mg, and -6.99 for NT-814 160 mg. For the BID II, mean change from baseline to week 12 was -1.38, -3.70, -2.34, -5.12, and -5.70, respectively, and for MenQOL, mean changes from baseline were -0.80, -0.76, -0.98, -1.60, -1.57, respectively.

“Strikingly, significant improvements were also shown for each domain of the MenQoL -- physical, psychosocial, vasomotor and sexual,” the authors reported.

Most adverse events (AEs) were mild or moderate and there were no serious AEs 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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