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°®¶¹´«Ã½.

Purdue Pharma L.P.

 

Tokyo, Japan and Stamford, Conn., U.S. – May 23, 2018 – °®¶¹´«Ã½. (CEO: Haruo Naito, “Eisai”) and Purdue Pharma L.P. (President and CEO: Craig Landau, “Purdue Pharma”) today announced they will present the latest data from two key Phase I clinical studies (Study 108 and Study 106) of investigational sleep/wake regulation agent lemborexant, including a comparison versus zolpidem tartrate extended release (zolpidem ER) and placebo on middle of the night awakening and next-morning effects, in poster presentations at the 32nd Annual Meeting of the Associated Professional Sleep Societies (SLEEP 2018) from June 2 to 6 in Baltimore, Maryland in the United States.

 

Of note, Eisai and Purdue Pharma will present data on a Phase I safety study (Study 108) that assessed the ability to awaken to an auditory stimulus and maintain postural stability (a predictor of risk for falls¹) and perform on tests of memory and attention in the middle of the night and the next morning. The study demonstrated that postural stability was statistically significantly worse for zolpidem ER 6.25 mg compared with both lemborexant 5 mg and 10 mg in healthy volunteers age 55 and older, and the primary endpoint was achieved. In this study, headache was the only adverse event (AE) observed in two or more people taking lemborexant.

 

Another Phase I study (Study 106), which evaluated residual next-morning effects via an on-road driving test, also achieved its primary objective, demonstrating no significant difference in next-morning driving performance versus placebo. This study was conducted versus placebo, with zopiclone included as a positive control, to evaluate potential next-morning impairment by measuring healthy adult and elderly participants’ driving performance. In this study, the most common AEs observed in the lemborexant arms were somnolence, headache, and dry mouth.

 

“It is important that a treatment for sleep/wake regulation allows a patient to not only sleep well, but also wake well. Sleeping well includes the ability to fall asleep and stay asleep through the night, and waking well includes the ability to wake in the middle of the night, if needed, or the next day without impairment,” said Russell Rosenberg, PhD, D.ABSM, a Principal Investigator in lemborexant studies and former Chairman of the Board of the National Sleep Foundation. “These studies provide important information about how lemborexant affects the ability to awaken after sleep.”

 

“Our aspiration toward sleep/wake regulation is to improve the ability to fall and stay asleep, and address risks related to impairment due to residual effects from many current sleep agents,” said Lynn Kramer, MD, Chief Clinical Officer and Chief Medical Officer, Neurology Business Group, Eisai. “These Phase I data provide important, clinically relevant information and strengthen our confidence in our investigational sleep/wake regulation agent, lemborexant, as we continue to work with Purdue Pharma to bring this investigational agent to patients living with sleep/wake disorders.”

 

“Since 2015, Purdue Pharma and Eisai have been working collaboratively on the development of lemborexant, and we look forward to sharing our data with the scientific community at the premier world forum for clinical sleep medicine,” said Marcelo Bigal, MD, PhD, Chief Medical Officer, Purdue Pharma. 

 

Lemborexant appears to impact an 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 excessive arousal or wakefulness without impeding the ability to awaken to external stimuli.

 

The following data will be presented by Eisai and Purdue Pharma at SLEEP 2018:

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<Notes to editors>

1. 1. °®¶¹´«Ã½ lemborexant

Lemborexant (development code: E2006), a dual orexin receptor antagonist, is Eisai’s in-house discovered and developed small molecule compound that inhibits orexin neurotransmission by binding competitively to the two subtypes of orexin receptors (orexin receptor 1 and 2). In individuals with sleep disorders, it is possible that the orexin system that regulates sleep and 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 by interfering with orexin neurotransmission. Therefore, Eisai and Purdue have been developing lemborexant as a treatment for multiple sleep disorders.

From the topline results of a Phase III clinical study (SUNRISE 1/Study 304) of lemborexant for insomnia disorder, the primary and major secondary endpoints were achieved, and together with the results from an ongoing Phase III clinical study (Study 303), Eisai and Purdue aim to submit applications seeking regulatory approval within fiscal 2018.

In addition, a Phase II clinical study of lemborexant in patients with irregular sleep-wake rhythm disorder (ISWRD) and mild to moderate Alzheimer's dementia is underway.

 

2. °®¶¹´«Ã½ Sleep Disorders

Population studies show that sleep disorders affect many more people worldwide than previously thought. 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.^2,3 Insomnia disorder is the most common sleep disorder, with persistent insomnia symptoms experienced by approximately 10 percent of the adult population.²