Eisai and Purdue Pharma L.P. Presented Lemborexant Data from Research Studies at ACNP Annual Meeting
Additional data published in the Journal of Clinical Sleep Medicine evaluated lemborexant doses for efficacy in insomnia disorder while minimizing residual morning sleepiness
WOODCLIFF LAKE, New Jersey & STAMFORD, Conn, December 7, 2017 – Eisai Inc., the U.S. subsidiary of Eisai Co., Ltd., and Purdue Pharma L.P. presented results from two research studies on the novel oral dual orexin receptor antagonist lemborexant during the American College of Neuropsychopharmacology (ACNP) 56th annual meeting taking place December 3-7 in Palm Springs, California.
The following posters were presented on Monday, December 4:
|Nonclinical evaluation of abuse liability for the novel orexin receptor antagonist lemborexant – comparison to suvorexant
||Shoji Asakura, Motohiro Shiotani, David V. Gauvin, Atsushi Fujiwara, Takashi Ueno, Nancy Bower, Carsten T. Beuckmann and Margaret Moline
|Efficacy of the novel dual orexin receptor antagonist lemborexant in a preclinical animal model of Irregular Sleep Wake Rhythm Disorder
||Carsten T. Beuckmann, Yoshihide Osada, Margaret Moline, Patricia Murphy and Andrew Satlin
The Asakura et al. poster presentation reported a non-clinical study demonstrating differences in lemborexant abuse liability when compared to a currently marketed insomnia treatment, suvorexant. In the Beuckmann et al. poster, description of a potential preclinical animal model of Irregular Sleep-Wake Rhythm Disorder (ISWRD) was presented, as well as the effects of lemborexant treatment on sleep/wake patterns and circadian rhythmicity in this animal model. ISWRD, a condition in which sleep/wake patterns are irregular and unpredictable throughout the day and nighttime hours, is commonly seen in Alzheimer’s disease patients and is associated with behavioral disturbances including agitation and restlessness.
A lemborexant phase 2 clinical study, “Lemborexant, A Dual Orexin Receptor Antagonist (DORA) for the Treatment of Insomnia Disorder: Results from a Bayesian, Adaptive, Randomized, Double-Blind, Placebo-Controlled Study,” was recently published in the Journal of Clinical Sleep Medicine. This study evaluated multiple doses of lemborexant, demonstrating statistically significant improvement in sleep initiation and sleep maintenance without increasing next-day residual sleepiness compared to placebo. Adverse events were mostly mild to moderate, included dose-related somnolence, and were consistent with the known pharmacology of orexin receptor antagonists.1
Discovered by Eisai, lemborexant is a dual orexin receptor antagonist that inhibits orexin neurotransmitter activity by binding competitively to two subtypes of orexin receptors (orexin receptor 1 and 2). Lemborexant is being jointly developed by Eisai and Purdue. Information about currently enrolling clinical studies is available at clinicaltrials.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 any investigational uses of such products will successfully complete clinical development or gain FDA approval.
ABOUT EISAI INC.
At Eisai Inc., human health care (hhc) is our goal. We give our first thoughts to patients and their families, and helping to increase the benefits health care provides. As the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., we have a passionate commitment to patient care that is the driving force behind our efforts to discover and develop innovative therapies to help address unmet medical needs.
Eisai is a fully integrated pharmaceutical business that operates in two global business groups: oncology and neurology (dementia-related diseases and neurodegenerative diseases). Each group functions as an end-to-end global business with discovery, development, and marketing capabilities. Our U.S. headquarters, commercial and clinical development organizations are located in New Jersey; our discovery labs are in Massachusetts and Pennsylvania; and our global demand chain organization resides in Maryland and North Carolina. To learn more about Eisai Inc., please visit us at www.eisai.com/US.
ABOUT PURDUE PHARMA L.P.
Purdue Pharma L.P. is a privately-held pharmaceutical company headquartered in Stamford, Conn. Purdue Pharma is part of a network of independent associated companies dedicated to providing patients and providers with innovative medicines. The company’s leadership and employees are committed to serving healthcare professionals, patients and caregivers by providing quality products and educational resources that make a positive impact on healthcare — and on lives. For more information, please visit www.purduepharma.com.
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1. Murphy P, Moline M, Mayleben D, Rosenberg R, Zammit G, Pinner K, Dhadda S, Hong Q, Giorgi L, Satlin A. Lemborexant, A Dual Orexin Receptor Antagonist (DORA) for the Treatment of Insomnia Disorder: Results From a Bayesian, Adaptive, Randomized, Double-Blind, Placebo-Controlled Study. J Clin Sleep Med. 2017 Nov 15;13(11):1289-1299.