Author Interviews, Eisai, Insomnia / 02.10.2020

MedicalResearch.com Interview with: Margaret Moline, PhD Executive Director, Neurology Business Group, Eisai, Inc Lemborexant International Program Lead and Global Medical Lead MedicalResearch.com: What is the background for this study? What are the main findings?
  • SUNRISE 2 was one of two pivotal Phase 3 studies evaluated in the U.S. Food and Drug Administration’s approval of DAYVIGO (lemborexant) CIV in December 2019.
  • SUNRISE 2 was a pivotal six-month placebo-controlled treatment trial with a 6-month active treatment period including adult patients age 18 or older who met DSM-5 criteria for insomnia disorder.
  • Patients were randomized to placebo (n=325), DAYVIGO 5 mg (n=323), or DAYVIGO 10 mg (n=323) once nightly for the first six months of the study (Treatment Period 1).
  • The primary efficacy endpoint was the mean change from baseline to end of treatment at six months for subjective sleep onset latency (sSOL; the estimated minutes from the time that the patient attempted to sleep until sleep onset).
  • Secondary efficacy endpoints were mean change from baseline to end of treatment at six months subjective sleep efficiency (sSE; the proportion of time spent asleep per time in bed) and subjective wake after sleep onset (sWASO; the minutes of wake from the onset of sleep until wake time). These endpoints were measured by sleep diary.
  • At Virtual SLEEP 2020, a post-hoc analysis of SUNRISE 2 was shared in an oral presentation, which looked specifically at the long-term efficacy and safety of lemborexant in elderly adults with insomnia disorder.
  • Insomnia disorder, a chronic condition with long-term consequences for health and well-being, is prevalent in older adults.
  • This analysis of the SUNRISE 2 data reflects new learnings on the sustained impact of DAYVIGO on sleep onset and sleep maintenance in an older patient population. 
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Author Interviews, JAMA, Sleep Disorders / 28.12.2019

MedicalResearch.com Interview with: Margaret Moline, PhD Lemborexant International Program Lead and Global Medical Lead Executive Director, Neurology Business Group Eisai, Inc.  MedicalResearch.com: What is the background for this study? This study, called SUNRISE 1, is one of two pivotal Phase 3 studies in the lemborexant clinical development program that supported the recent FDA approval of DAYVIGO (lemborexant).
  • On December 20, the U.S. Food and Drug Administration (FDA) approved DAYVIGO (lemborexant) 5 mg and 10 mg, an orexin receptor antagonist indicated for the treatment of adult patients with insomnia, which is characterized by difficulties with sleep onset and/or sleep maintenance.1
  • DAYVIGO will be commercially available following scheduling by the DEA, which is expected to occur within 90 days.
  • SUNRISE 1 was a one-month, randomized, double-blind, placebo- and active-controlled, multi-center, parallel-group clinical trial in adult female patients age 55 and older and male patients 65 years and older who met DSM-5 criteria for insomnia disorder. Patients were randomized to placebo (n=208), lemborexant 5 mg (n=266) or 10 mg (n=269), or active comparator (n=263) once nightly.1
  • The primary efficacy endpoint was the mean change in log-transformed latency to persistent sleep (LPS; defined as the number of minutes from lights off to the first 10 consecutive minutes of non-wakefulness) from baseline to end of treatment (Days 29/30), as measured by overnight polysomnography (PSG) monitoring.1
  • The pre-specified secondary efficacy endpoints in Study 2 were the mean change from baseline to end of treatment (Days 29/30) in sleep efficiency (SEF) and wake after sleep onset (WASO) measured by PSG.1
  • SUNRISE 1, lemborexant 5 mg and 10 mg demonstrated statistically significant superiority on the primary efficacy measure, LPS, compared to placebo. lemborexant 5 mg and 10 mg demonstrated statistically significant improvement in SEF and WASO compared to placebo.1
  • The effects of lemborexant at the beginning of treatment were generally consistent with later timepoints.
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