Eisai Co., Ltd. and Purdue Pharma L.P. yesterday announced that two key Phase 1 clinical studies (Study 108 and Study 106) of their investigational sleep/wake regulation agent lemborexant, including a comparison versus zolpidem tartrate extended release (zolpidem ER) and placebo on postural stability and other variables after middle-of-the-night awakening and the next-morning, will be presented at the 32nd Annual Meeting of the Associated Professional Sleep Societies (SLEEP 2018), June 2-6, Baltimore, MD. Lemborexant is currently being studied for the treatment of multiple sleep disorders. Positive topline results from Studies 108 and 106, as well as the first-ever Phase 3 head-to-head superiority comparison versus zolpidem ER, were previously announced.
Of note, Eisai and Purdue Pharma will present data on a Phase 1 safety study (Study 108) that assessed the ability to awaken to an auditory stimulus in the middle of the night, as well as maintain postural stability – a predictor of risk for falls – and perform on tests of memory and attention in the middle of the night and the next morning. Additional data from this study, including tests of memory and attention performance are forthcoming and will be submitted for presentation at a future scientific forum. The study demonstrated that postural stability was significantly worse for zolpidem ER 6.25 mg compared with both lemborexant 5 mg and 10 mg in healthy volunteers age 55 and older. The study also measured how quickly participants could return to sleep after being awakened as an exploratory endpoint. Headache was the only adverse event (AE) observed in two or more people taking lemborexant.
Another Phase 1 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 1 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. Lemborexant acts on the orexin neurotransmitter system and is believed to regulate sleep and wake by dampening excessive wakefulness without impeding the ability to awaken to external stimuli.
The following data will be presented by Eisai and Purdue Pharma at SLEEP 2018:
|Abstract Name||Session (All Times Eastern)|
|Auditory Awakening Threshold to Evaluate Ability to Awaken After Administration of Lemborexant Versus Zolpidem (Study 108)||Poster: 097 Poster Session: P27 Date: Tuesday, June 5 Time: 5:00 – 7:00 p.m.|
|Results From an On-Road Driving Performance Study in Non-elderly and Elderly Healthy Subjects with Dual Orexin Receptor Antagonist Lemborexant (Study 106)||Poster: 099 Poster Session: P27 Date: Tuesday, June 5 Time: 5:00 – 7:00 p.m.|
Discovered by Eisai, lemborexant – an investigational sleep/wake regulation agent – is being jointly developed by Eisai and Purdue Pharma. Information about ongoing clinical studies is available atclinicaltrials.gov.
This release discusses investigational uses of agents 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.