Eisai Inc. - Extensive Analyses of Phase 3 Data for Investigational Lemborexant Assess Efficacy and Safety Profile for the Potential Treatment of Insomnia in Adults.
ENPNewswire-June 12, 2019--Eisai Inc. - Extensive Analyses of Phase 3 Data for Investigational Lemborexant Assess Efficacy and Safety Profile for the Potential Treatment of Insomnia in Adults
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Release date- 11062019 - WOODCLIFF LAKE - Eisai Inc. today announced new long-term safety and pooled analyses from the Phase 3 clinical development program for lemborexant, an investigational agent for sleep-wake regulation, currently being studied for the treatment of insomnia, a sleep-wake disorder, and irregular sleep-wake rhythm disorder (ISWRD).
These analyses of lemborexant assessed its efficacy on key insomnia measures, improvement in patient daytime function and long-term safety. Additionally, sleep architecture data were presented from the Phase 3 SUNRISE 1 study. The findings were presented at the 33rd annual meeting of the Associated Professional Sleep Societies (SLEEP 2019) in San Antonio.
'The Phase 3 pooled analyses provide new insights into lemborexant's impact on insomnia severity and several other important sleep measures, including sleep onset, sleep maintenance, and next-day functioning. As insomnia is a chronic condition, the long-term safety data are important for both potential patients and health care professionals,' said Russell Rosenberg, PhD, D.ABSM, a principal investigator in the lemborexant studies and former Chairman of the Board of the National Sleep Foundation. 'Many patients battle sleepless nights and can struggle to function the next day. These new findings presented at SLEEP 2019 provide further support for the potential role of lemborexant as a treatment option for the millions of people in the U.S. suffering from insomnia.'
Earlier this year, the U.S. Food and Drug Administration accepted for review the New Drug Application for lemborexant for the treatment of insomnia. A target Prescription Drug User Fee Act date is set for December 27, 2019.
'Treatment of insomnia can be challenging as it should address not only sleep onset and maintenance, but also the patient's ability to wake ready the next day,' said Lynn Kramer, MD, Chief Clinical Officer and Chief Medical Officer, Neurology Business Group, Eisai. 'Patients who participated in our pivotal Phase 3 studies and were treated with lemborexant experienced a reduction in Insomnia Severity Index scores, which include measures of daytime functioning.'
Key safety and efficacy data presented at SLEEP 2019 are from SUNRISE 1 (Study 304), a one-month study in adults 55 and over, SUNRISE 2 (Study 303), a long-term study in adults 18 and over, and pooled analyses from the two Phase 3 clinical studies. Some of these data were derived from post hoc and exploratory analyses. Multiplicity adjustments were not applied, and these results should be interpreted appropriately.
Lemborexant Treatment for Insomnia: Six-month Safety (Poster 102/Abstract 0367)
This analysis presents safety results from the first six-month placebo-controlled period of the 12-month Phase 3 study, SUNRISE 2, which included 947 patients (lemborexant 5 mg, n=314, lemborexant 10 mg, n=314...
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