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     127  0 Kommentare Daridorexant Phase 3 results in insomnia presented at SLEEP 2020

    Allschwil, Switzerland – August 28, 2020

    Idorsia Ltd (SIX: IDIA) today announced that the positive results from the first pivotal Phase 3 study (evaluating 25 and 50 mg doses) of its investigational dual orexin receptor antagonist, daridorexant, in adult and elderly patients with insomnia, were presented by Dr Thomas Roth at SLEEP 2020. The study demonstrated efficacy of treatment with daridorexant on objective and subjective sleep parameters, and daytime functioning, with no next-morning residual effect.

    The Associated Professional Sleep Societies (APSS) event, SLEEP 2020, is the world’s largest meeting devoted entirely to clinical sleep medicine, and sleep and circadian research and is currently taking place as a virtual meeting. The presentation, entitled “Efficacy and safety of daridorexant in adult and elderly patients with insomnia”, is available for on-demand replay for registered participants through August 1, 2021.

    Dr Thomas Roth, PhD, Director of the Sleep Disorder and Research Center at Henry Ford Hospital, commented:
    “Daridorexant, a new dual orexin receptor antagonist, has a pharmacokinetic and pharmacodynamic profile optimized for sleep onset and duration of action to improve night-time efficacy, without residual effects. These pharmacological properties led us to hypothesize that daridorexant could also improve the impaired daytime functioning frequently observed in insomnia. A new patient-reported outcome instrument was developed – and validated according to FDA requirements – to specifically assess daytime functioning in patients with insomnia and we included it in the Phase 3 program. The results have been outstanding.”

    The Phase 3 trial was designed to measure the impact of daridorexant on objective and subjective sleep parameters as well as on daytime functioning, and to evaluate safety, in patients with moderate to severe insomnia. Sleep variables were assessed using polysomnography for wake after sleep onset (WASO) and latency to persistent sleep (LPS). A sleep diary questionnaire was used to measure subjective total sleep time (sTST). Daytime functioning was assessed using a newly developed and validated patient-reported outcome instrument, the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ). The IDSIQ comprises 14 items grouped into three domains that reflect daytime effects of insomnia that are commonly encountered in clinical practice: Alert/Cognition, Mood, and Sleepiness/Tiredness.

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    Daridorexant Phase 3 results in insomnia presented at SLEEP 2020 Allschwil, Switzerland – August 28, 2020 Idorsia Ltd (SIX: IDIA) today announced that the positive results from the first pivotal Phase 3 study (evaluating 25 and 50 mg doses) of its investigational dual orexin receptor antagonist, daridorexant, in …

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