SYS-CON MEDIA Authors: Yeshim Deniz, Pat Romanski, Carmen Gonzalez, Zakia Bouachraoui, Gary Arora

News Feed Item

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



Long-term efficacy and safety evaluation in patients with insomnia, a sleep-wake disorder, met primary and key secondary efficacy objectives

TOKYO, Oct 17, 2018 - (JCN Newswire) - 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 Sleep Disorders

Population studies show that sleep disorders affect many more people worldwide than previously thought.(2) Insomnia disorder is characterized by difficulty falling sleep, staying asleep or both,
despite an adequate opportunity to sleep, that can lead to daytime consequences such as fatigue, difficulty concentrating and irritability.(3),(4) Insomnia disorder is the most common sleep disorder, with persistent insomnia symptoms experienced by approximately 10 percent of the adult population.(2),(3)

Sleeping well is essential for good health, including brain health. Poor sleep is associated with a wide range of health consequences, including an increased risk of hypertension, accidental injury, diabetes, obesity, depression, heart attack, stroke and dementia, as well as adverse effects on mood and behavior.(4),(5)

Experimental studies in animals and humans provide evidence of associations between sleep and disease risk factors, diseases and mortality.(2),(6) Studies suggest an optimal sleep duration between seven and eight hours.(2),(6) Women are 1.4 times more likely than men to suffer from insomnia.(7) Older adults also have higher prevalence of insomnia; aging is often accompanied by changes in sleep patterns, including disrupted sleep, frequent waking and early waking, that can lead to less sleep time.(8)

About Purdue Pharma L.P.

Purdue Pharma L.P. develops and provides prescription medicines that meet the evolving needs of healthcare professionals, patients, and caregivers. We were founded by physicians and we are currently led by a physician. Beyond our efforts to provide quality medications, Purdue is committed to supportingnational, regional and local collaborations to drive innovations in patient care. Privately held, Purdue is pursuing a pipeline of new medications and technologies through internal research & development and strategic industry partnerships. For more information, please visit www.purduepharma.com.

(1) Eisai Inc. Long-term study of lemborexant in insomnia disorder (E2006-G000-303).
(2) Ferrie JE, et al. Sleep epidemiology - a rapidly growing field. Int J Epidemiol. 2011;40(6):1431-1437.
(3) Ohayon MM, et al. Epidemiology of insomnia: what we know and what we still need to learn. Sleep Med Rev. 2002;6(2):97-111.
(4) Institute of Medicine. Sleep disorders and sleep deprivation: An unmet public health problem. Washington, DC: National Academies Press. 2006.
(5) Pase MP, Himali JJ, Grima NA, et al. Sleep architecture and the risk of incident dementia in the community. Neurology. 2017;89(12):1244-1250.
(6) Trenell MI, et al. Sleep and metabolic control: waking to a problem? Clin Exp Pharmacol Physiol. 2007;34:1-9.
(7) Zhang B, Wing, YK. Sex differences in insomnia: a meta-analysis. Sleep. 2006;29(1):85-93.
(8) Ohayon MM, et al. Meta-analysis of quantitative sleep parameters from childhood to old age in healthy individuals: developing normative sleep values across the human lifespan. Sleep. 2004;27:1255-1273.

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.

Source: Eisai

Contact:
Public Relations Department,
Eisai Co., Ltd.
+81-3-3817-5120




Copyright 2018 JCN Newswire . All rights reserved.

More Stories By ACN Newswire

Copyright 2008 ACN Newswire. All rights reserved. Republication or redistribution of ACN Newswire content is expressly prohibited without the prior written consent of ACN Newswire. ACN Newswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
In today's always-on world, customer expectations have changed. Competitive differentiation is delivered through rapid software innovations, the ability to respond to issues quickly and by releasing high-quality code with minimal interruptions. DevOps isn't some far off goal; it's methodologies and practices are a response to this demand. The demand to go faster. The demand for more uptime. The demand to innovate. In this keynote, we will cover the Nutanix Developer Stack. Built from the foundat...
Alan Hase is Vice President of Engineering and Chief Development Officer at Big Switch. Alan has more than 20 years of experience in the networking industry and leading global engineering teams which have delivered industry leading innovation in high end routing, security, fabric and wireless technologies. Alan joined Big Switch from Extreme Networks where he was responsible for product strategy for its secure campus switching, intelligent mobility and campus orchestration products. Prior to Ext...
Darktrace is the world's leading AI company for cyber security. Created by mathematicians from the University of Cambridge, Darktrace's Enterprise Immune System is the first non-consumer application of machine learning to work at scale, across all network types, from physical, virtualized, and cloud, through to IoT and industrial control systems. Installed as a self-configuring cyber defense platform, Darktrace continuously learns what is ‘normal' for all devices and users, updating its understa...
The level of trust we have with individuals, businesses, and technology affects our lives daily. This is important to remember when discussing new technologies. For example, our level of trust is a critical factor when evaluating a new technology as a potential solution for providing business value. Given the importance of trust, imagine one's reaction upon hearing that blockchain is a "trustless trust" system. On the surface, that does sound like an oxymoron. This paper discusses how "trustless...
In an age of borderless networks, security for the cloud and security for the corporate network can no longer be separated. Security teams are now presented with the challenge of monitoring and controlling access to these cloud environments, as they represent yet another frontier for cyber-attacks. Complete visibility has never been more important-or more difficult. Powered by AI, Darktrace's Enterprise Immune System technology is the only solution to offer real-time visibility and insight into ...
Financial enterprises in New York City, London, Singapore, and other world financial capitals are embracing a new generation of smart, automated FinTech that eliminates many cumbersome, slow, and expensive intermediate processes from their businesses. Accordingly, attendees at the upcoming 23rd CloudEXPO, June 24-26, 2019 at Santa Clara Convention Center in Santa Clara, CA will find fresh new content in full new FinTech & Enterprise Blockchain track.
Every organization is facing their own Digital Transformation as they attempt to stay ahead of the competition, or worse, just keep up. Each new opportunity, whether embracing machine learning, IoT, or a cloud migration, seems to bring new development, deployment, and management models. The results are more diverse and federated computing models than any time in our history.
Intel is an American multinational corporation and technology company headquartered in Santa Clara, California, in the Silicon Valley. It is the world's second largest and second highest valued semiconductor chip maker based on revenue after being overtaken by Samsung, and is the inventor of the x86 series of microprocessors, the processors found in most personal computers (PCs). Intel supplies processors for computer system manufacturers such as Apple, Lenovo, HP, and Dell. Intel also manufactu...
Blockchain has shifted from hype to reality across many industries including Financial Services, Supply Chain, Retail, Healthcare and Government. While traditional tech and crypto organizations are generally male dominated, women have embraced blockchain technology from its inception. This is no more evident than at companies where women occupy many of the blockchain roles and leadership positions. Join this panel to hear three women in blockchain share their experience and their POV on the futu...
Concerns about security, downtime and latency, budgets, and general unfamiliarity with cloud technologies continue to create hesitation for many organizations that truly need to be developing a cloud strategy. Hybrid cloud solutions are helping to elevate those concerns by enabling the combination or orchestration of two or more platforms, including on-premise infrastructure, private clouds and/or third-party, public cloud services. This gives organizations more comfort to begin their digital tr...
In very short order, the term "Blockchain" has lost an incredible amount of meaning. With too many jumping on the bandwagon, the market is inundated with projects and use cases that miss the real potential of the technology. We have to begin removing Blockchain from the conversation and ground ourselves in the motivating principles of the technology itself; whether it is consumer privacy, data ownership, trust or even participation in the global economy, the world is faced with serious problems ...
Data center, on-premise, public-cloud, private-cloud, multi-cloud, hybrid-cloud, IoT, AI, edge, SaaS, PaaS... it's an availability, security, performance and integration nightmare even for the best of the best IT experts. Organizations realize the tremendous benefits of everything the digital transformation has to offer. Cloud adoption rates are increasing significantly, and IT budgets are morphing to follow suit. But distributing applications and infrastructure around increases risk, introdu...
Cloud Storage 2.0 has brought many innovations, including the availability of cloud storage services that are less expensive and much faster than previous generations of cloud storage. Cloud Storage 2.0 has also delivered new and faster methods for migrating your premises storage environment to the cloud and the concept of multi-cloud. This session will provide technical details on Cloud Storage 2.0 and the methods used to efficiently migrate from premises-to-cloud storage. This session will als...
For enterprises to maintain business competitiveness in the digital economy, IT modernization is required. And cloud, with its on-demand, elastic and scalable principles has resoundingly been identified as the infrastructure model capable of supporting fast-changing business requirements that enterprises are challenged with, as a result of our increasingly connected world. In fact, Gartner states that by 2022, 28% of enterprise IT spending will have shifted to cloud. But enterprises still must d...
Cloud-Native thinking and Serverless Computing are now the norm in financial services, manufacturing, telco, healthcare, transportation, energy, media, entertainment, retail and other consumer industries, as well as the public sector. The widespread success of cloud computing is driving the DevOps revolution in enterprise IT. Now as never before, development teams must communicate and collaborate in a dynamic, 24/7/365 environment. There is no time to wait for long development cycles that pro...