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Eisai and Purdue Pharma Announce Positive Topline Results of SUNRISE 2, the Second Phase 3 Pivotal Study of Lemborexant

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Eisai Co., Ltd. and Purdue Pharma L.P. announced positive topline results from SUNRISE 2, a long-term Phase 3 efficacy and safety evaluation of lemborexant, an investigational agent for sleep-wake regulation currently being studied for the potential treatment of multiple sleep-wake disorders.

Topline results reported today are the primary and key secondary outcomes of the study from the six-month, placebo-controlled treatment period; the study is ongoing to 12 months. Eisai and Purdue Pharma plan to present full results from SUNRISE 2 at upcoming medical meetings in 2019.

SUNRISE 2 enrolled more than 900 adult patients (18 to 88 years of age) with insomnia disorder, characterized by difficulty falling asleep and/or staying asleep. The study met the pre-specified primary and key secondary efficacy objectives assessed by patient self-reports (sleep diaries). At the end of the six-month, placebo-controlled treatment period, lemborexant 5 mg and 10 mg provided statistically significant improvement in subjective sleep onset latency compared to placebo, the study's primary endpoint.

Lemborexant 5 mg and 10 mg also provided statistically significant improvement in sleep maintenance variables of subjective sleep efficiency and subjective wake after sleep onset compared to placebo, which were the study's key secondary endpoints. Daily functioning, as measured by the Insomnia Severity Index, was also improved by both lemborexant 5 mg and 10 mg compared to placebo. Overall discontinuation rates due to AEs were comparable between placebo and lemborexant 5 mg, and higher for lemborexant 10 mg.

"As a clinician and researcher treating patients with insomnia and other sleep-wake disorders for 30 years, for me, successful treatment means that patients fall asleep fast, sleep well, and wake well, without functional impairment, or loss of effect over time," said Russell Rosenberg, PhD, D.ABSM, a Principal Investigator in the lemborexant studies and former Chairman of the Board of the National Sleep Foundation. "The results of SUNRISE 2 are particularly encouraging for the many patients who suffer from chronic insomnia."

The results of SUNRISE 2 build on a growing body of knowledge supporting the development of lemborexant, including SUNRISE 1, a zolpidem tartrate extended release as well as key safety studies evaluating for impairment as assessed by the ability to maintain postural stability - a predictor of risk for falls - after middle-of-the-night and next morning awakening and next-morning driving performance.

"Our aspiration for lemborexant is to bring to the millions of patients suffering from insomnia and other sleep- wake disorders an agent for sleep-wake regulation that improves their ability to fall asleep and stay asleep, and maintains efficacy over time," said Lynn Kramer, MD, Chief Clinical Officer and Chief Medical Officer, Neurology Business Group, Eisai. "In SUNRISE 2, lemborexant improved time to sleep onset and sleep maintenance over a six-month period. With these results, we now look forward to proceeding with regulatory submissions for lemborexant to bring to patients a long-term treatment option for treating the sleep-wake disorder, insomnia."

Lemborexant appears to impact the underlying reason for a patient's inability to sleep well. Lemborexant acts on the orexin neurotransmitter system and is believed to regulate sleep and wake by dampening wakefulness without impeding the ability to awaken to external stimuli.
"These lemborexant study results for sleep onset and sleep maintenance are critical parts of the sleep-wake paradigm for those suffering from insomnia," said Marcelo Bigal, MD, PhD, Chief Medical Officer, Purdue Pharma. "We understand the importance of sleep-wake regulation to overall health and patient outcomes and, alongside our collaboration partner, Eisai, look forward to continued research as part of our commitment to a variety of patient populations with sleep-wake disorders."

Discovered by Eisai, lemborexant is being jointly developed by Eisai and Purdue Pharma. Information about ongoing clinical studies is available at clinicaltrials.gov.

This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that such investigational agent will successfully complete clinical development or gain health authority approval.

About Lemborexant
Lemborexant, an investigational dual orexin receptor antagonist, is Eisai's in-house discovered and developed small molecule compound which inhibits orexin neurotransmission, or signaling, by binding competitively to two subtypes of orexin receptors (orexin receptor 1 and 2). In individuals with sleep-wake disorders, it is possible that the orexin system which regulates wakefulness is not functioning normally. During normal periods of sleep, orexin system activity is suppressed, suggesting it is possible to purposefully counteract inappropriate wakefulness and facilitate the initiation and maintenance of sleep.

Eisai and Purdue Pharma are investigating lemborexant as a potential treatment option for insomnia and other sleep-wake disorders. A Phase 2 clinical study of lemborexant in patients with irregular sleep-wake rhythm disorder and mild to moderate Alzheimer's dementia is underway.

About SUNRISE 2 / Study 303(1)
A 12-month multicenter, global, randomized, controlled, double-blind, parallel group study of 971 male or female adult participants (18 to 88 years of age) with insomnia disorder, including a screening and two-week placebo run-in period, a 52-week treatment period and a two-week follow- up period. All patients received lemborexant for at least six months during the study. Lemborexant 5 mg, 10 mg or matching placebo was taken orally in tablet form at home each night immediately before the patient intended to try to sleep for the first six months of study. The primary outcome measure was mean change from baseline in subjective sleep onset latency after six months of placebo-controlled treatment. Key secondary outcome measures were mean change from baseline in subjective sleep efficiency and subjective wake after sleep onset after six months of placebo- controlled treatment.

About Eisai
Eisai Co., Ltd. is a leading global research and development-based pharmaceutical company headquartered in Japan. We define our corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides," which we call our human health care philosophy. With approximately 10,000 employees working across our global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realize our human health care philosophy by delivering innovative products in various therapeutic areas with high unmet medical needs, including Oncology and Neurology.

As a global pharmaceutical company, our mission extends to patients around the world through our investment and participation in partnership-based initiatives to improve access to medicines in developing and emerging countries. For more information about Eisai Co., Ltd., please visit www.eisai.com

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