공시 • Mar 14
Idorsia Announces the Publication of Positive Data with Daridorexant in Patients with Chronic Insomnia and Nocturia
Idorsia Ltd. announced the publication of "A randomized cross-over trial of daridorexant for the treatment of chronic insomnia and nocturia" in the Journal of Sleep Research. The new data provides evidence of the benefit of Idorsia's dual orexin receptor antagonist, daridorexant (QUVIVIQ™?), at a daily dose of 50 mg, in patients aged =55 years with chronic insomnia and comorbid nocturia, with efficacy data on symptoms of both conditions, improvement in daytime functioning, and a good safety and tolerability profile. Chronic insomnia is defined as difficulty initiating and/or maintaining sleep at least three times a week for a minimum of three months and a significant negative impact on daytime functioning. For these people, it is difficult to understand the impact that nocturia can have. The patients enrolled in this study are waking 3, 4 and sometimes 5 or more times during the night to use the toilet, so quite severe nocturia symptoms. When combined with insomnia, the patients are poorly affected by the disruption, with many not able to function well the next day. The results in the study show that the patients are able to sleep longer before the first visit to the toilet and need to go fewer times, these are certainly clinically meaningful results." In total, 60 patients - equally split between male and female patients - aged 55 or older with insomnia and comorbid noCTuria participated in this multi-national, multi-center, double-blind, randomized, placebo-controlled, 2-way cross-over study. The study consisted of 2 treatment periods of 4 weeks each, separated by a 2-3-week washout period. In the study, daridorexants 50 mg significantly improved subjective total sleep time (sTST) from baseline to Week 4 of treatment (primary endpoint) and other measures of sleep and daytime functioning. No serious AEs/AEs leading to discontinuation were reported in the study. Importantly, in terms of adverse events of special interest, there were no urinary incontinences, and no falls observed in patients treated with daridorexant. In total, 60 patients – equally split between male and female patients – aged 55 or older with insomnia and comorbid nocturia participated in this multi-national, multi-center, double-blind, randomized, placebo-controlled, 2-way cross-over study. The study consisted of 2 treatment periods of 4 weeks each, separated by a 2-3-week washout period. The primary objective of the study was to assess the efficacy of daridorexant 50 mg daily on insomnia by measuring subjective total sleep time (sTST) by the Sleep Diary Questionnaire (SDQ). Other sleep-related endpoints included the overall rating of the insomnia severity by the Insomnia Severity Index© (ISI©), and SDQ-derived variables like quality of sleep visual analog scale (VAS), depth of sleep VAS, daytime alertness VAS, daily ability to function VAS, and number of awakenings. The secondary objective was to assess the efficacy of daridorexant on nocturia by evaluating the number of nocturnal voids, the time to the first nocturnal void, each voiding volume (nighttime and daytime) including total volume, lower urinary tract symptoms (LUTS) sub-score using the International Consultation on Incontinence Questionnaire (ICIQ) -MLUTS and -FLUTS for male and female subjects, and quality of life relative to nocturia, assessed by ICIQ Nocturia Quality of Life (ICIQ-NQoL).Other endpoints included a change in daytime functioning (Insomnia Daytime Symptoms and Impacts Questionnaire score, IDSIQ). Other objectives focused on patient’s overall assessment ratings of their condition and symptoms, as well as patients’ safety using various questionnaires.