Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) today announced that latest data on lemborexant, an investigational sleep-wake regulation agent being studied for the treatment of sleep-wake disorders, including insomnia and Irregular Sleep-Wake Rhythm Disorder (ISWRD) associated with Alzheimer’s disease/dementia will be presented at World Sleep Congress (World Sleep 2019), from September 20 to 25 in Vancouver, Canada.
At this congress, oral presentations will be given including the first congress presentation about the analysis of results at the end of 12 months from phase III clinical study (SUNRISE-2) evaluating long-term effectiveness and safety of lemborexant in patients with insomnia and the effect on sleep architecture in older adults with insomnia from phase III clinical study (SUNRISE-1) evaluating the efficacy and safety of lemborexant. Furthermore, one more oral presentation for nonclinical research about efficacy of lemborexant with ISWRD model mouse will be held. In addition, six poster presentations, including on the effect of lemborexant on fatigue by patient-reported outcomes from the 6-month placebo-controlled treatment period of SUNRISE-2 as a subgroup analysis will be given.
Lemborexant acts on the orexin neurotransmitter system and is believed to facilitate sleep onset, sleep maintenance, and wake by regulating sleep-wake rhythm.
Lemborexant is being developed for the treatment of sleep-wake disorders including insomnia disorder, and Eisai has submitted new drug applications seeking approval of lemborexant for use in the treatment of insomnia disorder in the United States (December 2018), Japan (March 2019), and Canada (August 2019), respectively. Additionally, a Phase II clinical study of lemborexant in patients with ISWRD associated with mild to moderate Alzheimer’s dementia is underway. For the ongoing clinical studies, please visit clinicaltrials.gov.
Through the development of lemborexant, Eisai aims for contribution for rework/recovery by bringing an active daytime life by fast sleep onset and good quality sleep to patients suffering from sleep-wake disorders including insomnia, and is striving to further contribute to satisfying unmet medical needs and improve the benefits to patients and their families.
Public Relations Department,
Eisai Co., Ltd.