New Drug Application for Insomnia Disorder Treatment Lemborexant Submitted in the United States

TOKYO and STAMFORD, Conn., Jan. 15, 2019 /PRNewswire/ -- Eisai Co., Ltd. (CEO: Haruo Naito, "Eisai") and Purdue Pharma L.P. (President and CEO: Craig Landau, MD, "Purdue Pharma") today announced that a new drug application has been submitted to the U.S. Food and Drug Administration (FDA) for lemborexant, an investigational agent for sleep-wake regulation, seeking approval for the treatment of insomnia, a sleep-wake disorder.

This application was based on the results of two pivotal Phase 3 clinical studies in patients with insomnia, SUNRISE 1 (Study 304) and SUNRISE 2 (Study 303), enrolling approximately 2,000 patients, as well as important safety studies, including assessment of postural stability after middle-of-the-night awakening and a next-morning driving study. SUNRISE 1, a one-month, double-blind, placebo-controlled study, included the first ever Phase 3 head-to-head comparison versus zolpidem ER and objectively assessed sleep parameters (time to sleep onset, sleep efficiency, and wake after sleep onset) resulting in the largest (objective) polysomnography dataset collected to date in patients with insomnia. SUNRISE 2 was a 12-month study and subjectively assessed for ability to fall asleep and stay asleep based on patient self reports (sleep diaries).

Lemborexant, which 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, is being jointly developed by Eisai and Purdue Pharma for the treatment of multiple sleep-wake disorders, including insomnia disorder. In addition to the treatment of insomnia disorder, a Phase 2 clinical study of lemborexant in patients with irregular sleep-wake rhythm disorder and mild to moderate Alzheimer's dementia is underway. Information about ongoing clinical studies is available at clinicaltrials.gov.

Eisai and Purdue Pharma are striving to address new unmet medical needs and to improve the lives of patients and their families.

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 an investigational agent will successfully complete clinical development or gain health authority approval.

<Notes to editors>

    1. About LemborexantLemborexant is a novel investigational small molecule
       compound, discovered and developed by Eisai in-house scientists, that
       inhibits orexin signaling by binding competitively to both orexin
       receptor subtypes (orexin receptor 1 and 2). In individuals with normal
       daily sleep-wake rhythms, orexin signaling is believed to promote periods
       of wakefulness. In individuals with sleep-wake disorders, it is possible
       that orexin signaling which regulates wakefulness is not functioning
       normally, suggesting that inhibiting inappropriate orexin signaling may
       enable initiation and maintenance of sleep.



    2. About SUNRISE 1 (Study 304)SUNRISE 1 was a multicenter, randomized,
       double-blind, placebo-controlled, active comparator, parallel-group study
       evaluating the efficacy and safety of lemborexant in 1,006 male or female
       adult patients 55 years and older (45 percent of patients were 65 years
       and older) with insomnia disorder conducted in North America and Europe.
       SUNRISE 1 included a pre-randomization phase of up to 35 days (including
       a two-week placebo run-in period) and a randomization phase comprised of
       a 30-day treatment period and a minimum two-week period without treatment
       prior to the end-of-study visit. In this study, patients were randomized
       to receive placebo or one of three treatment regimens (lemborexant 5 mg,
       lemborexant 10 mg, zolpidem ER 6.25 mg). The primary objective for
       SUNRISE 1 was to demonstrate using polysomnography that lemborexant at
       either the 5 mg or 10 mg dose is superior to placebo on objective sleep
       onset, as measured by latency to persistent sleep after the last two
       nights of one month of treatment. Key secondary objectives included
       change from baseline in sleep efficiency and wake after sleep onset
       (WASO) for both lemborexant doses compared to placebo, and WASO in the
       second half of the night (WASO2H) for both lemborexant doses compared to
       zolpidem ER, each after the last two nights of one month of treatment.



    3. About SUNRISE 2 (Study 303)SUNRISE 2 was a 12-month multicenter, global,
       randomized, controlled, double-blind, parallel-group study of the
       efficacy and safety of lemborexant in 949 male or female adult
       participants 18 to 88 years of age with insomnia disorder. SUNRISE 2
       included a pre-randomization phase of up to 35 days (including a two-week
       placebo run-in period) and a randomization phase comprised of a six-month
       placebo-controlled treatment period, a six-month period of only active
       treatment and a two-week period without treatment prior to the
       end-of-study-visit. In this study, during the placebo-controlled
       treatment period, patients were randomized to receive placebo or one of
       two treatment regimens (lemborexant 5 mg or 10 mg). During the
       active-only treatment period, patients who received placebo during the
       first period were re-randomized to receive lemborexant 5 mg or 10 mg.
       Patients who received active treatment during the first period continued
       on the treatment to which they were originally randomized. The primary
       objective was to determine the efficacy of lemborexant 5 mg and 10 mg
       compared to placebo on patient-reported (subjective) sleep onset latency
       after six months of treatment. Key secondary endpoints were mean change
       from baseline in subjective sleep efficiency and subjective wake after
       sleep onset (sWASO) for lemborexant 5 mg and 10 mg compared to placebo
       after six months of treatment.









    4. About Sleep DisordersPopulation studies show that sleep disorders affect
       many more people worldwide than previously thought. Insomnia disorder is
       the most common sleep disorder affecting approximately 30 percent of the
       adult population worldwide. Insomnia disorder is characterized by
       difficulty falling asleep, staying asleep or both, despite an adequate
       opportunity to sleep, which can lead to daytime consequences such as
       fatigue, difficulty concentrating and irritability. 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.Experimental studies in animals and humans provide
       evidence of associations between sleep and disease risk factors, diseases
       and mortality. Studies suggest an optimal sleep duration between seven
       and eight hours.Women are 1.4 times more likely than men to suffer from
       insomnia. 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.







    5. About Eisai Co., LtdEisai 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 (hhc) philosophy. With over 10,000
       employees working across our global network of R&D facilities,
       manufacturing sites and marketing subsidiaries, we strive to realize our
       hhc philosophy by delivering innovative products in various therapeutic
       areas with high unmet medical needs, including Neurology and Oncology. 
       Furthermore, we invest and participate in several 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.

    6. 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 Pharma is committed to supporting national,
       regional and local collaborations to drive innovations in patient care.
       Privately held, Purdue Pharma 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.

     
              Contacts:





     
              Eisai Inc.      
     Purdue Pharma L.P.



     Michele Randazzo           
     Danielle Lewis



     +1-201-746-2979            
     +1-203-588-7653



     michele_randazzo@eisai.com 
     danielle.lewis@pharma.com

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SOURCE Eisai Inc.