Eisai Inc. - Lemborexant Respiratory Safety Data Presented at SLEEP 2019.
ENPNewswire-June 12, 2019--Eisai Inc. - Lemborexant Respiratory Safety Data Presented at SLEEP 2019
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Release date- 11062019 - WOODCLIFF LAKE - Eisai Inc. today announced data on the respiratory safety of investigational lemborexant with multiple and single dosing in healthy adult and elderly individuals, as well as in those with mild obstructive sleep apnea (OSA).
Lemborexant, an investigational agent for sleep-wake regulation, is currently being studied for the treatment of insomnia, a sleep-wake disorder, and irregular sleep-wake rhythm disorder (ISWRD). These studies were presented at the 33rd annual meeting of the Associated Professional Sleep Societies (SLEEP 2019) in San Antonio.
Insomnia is a chronic condition that leads to significant distress or impairment in daily functioning and often affects the ability of patients to wake ready the next day.1 Respiratory safety is an important consideration in the treatment of insomnia, particularly in vulnerable individuals, such as the elderly and those with OSA.2 Some currently available treatment options, including sedative-hypnotic medications, are associated with central respiratory depression.3
'Given the respiratory concerns regarding the treatment of insomnia and the vital importance of proper breathing during sleep, it is crucial that respiratory patterns are evaluated, particularly when caring for vulnerable populations,' said Lynn Kramer, MD, Chief Clinical Officer and Chief Medical Officer, Neurology Business Group, Eisai.
Earlier this year, the U.S. Food and Drug Administration accepted for review the New Drug Application for lemborexant for the treatment of insomnia. A target Prescription Drug User Fee Act date is set for December 27, 2019.
Key respiratory safety data presented at SLEEP 2019 are from Study 102, a two-part study on the respiratory safety of lemborexant.
Respiratory Safety of Lemborexant in Adult and Elderly Subjects With Mild Obstructive Sleep Apnea (Poster 103/Abstract 0429)
This Phase 1, multicenter, multiple-dose, randomized, double-blind, placebo-controlled, two-period crossover study examined pharmacodynamic respiratory safety parameters in subjects with mild OSA following a single dose or multiple doses of lemborexant. Thirty-six adult and elderly subjects (aged 18 to 90 years; mean age=57.2) with mild OSA completed the study and were randomized to receive either lemborexant 10 mg or placebo for two...
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