Eisai announced Lemborexant's active research data on sleep disorders
March 08, 2018 Source: Sina Pharmaceutical
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];On March 7, Japan Eisai Pharmaceuticals and Purdue Pharmaceuticals of the United States announced the results of a positive top-line study of a number of clinical trials of the drug lemborexant. Lemborexant is an ongoing sleep and wakefulness drug and is currently undergoing therapeutic research for a variety of sleep disorders.
The critical clinical phase 3 study SUNRISE 1 was compared with placebo and the active control drug zolpidem ER, which was administered to patients who were 55 years of age or older and had difficulty falling asleep overnight. And key secondary study endpoints. The study has a reliable polysomnography (PSG) dataset, the first phase 3 study with pre-specified endpoints, compared to zolpidem, for sleep initiation and sleep maintenance variables (including the second half of the night) Baseline changes in awake, which is the most common insomnia time in older patients, were measured. The study used objective PSG to evaluate whether 5 mg and 10 mg of lemborexant were superior to 6.25 mg of zolpidem extended release and placebo. In this study, the proportion of patients who discontinued because of adverse events (AEs) was comparable to placebo, and the most common AEs in the lemborexant arm were headache and lethargy.
In addition, the Phase 1 Safety Study (Study 108) evaluated the ability to maintain posture stability, arouse auditory stimuli, and perform memory and attention tests in the middle of the night. Postural stability and memory and attention tests are repeated shortly after waking up. The study also measured the rate at which participants recovered to sleep after being awakened. The study reached the primary endpoint, indicating that 6.25 mg of zolpidem was much less stable in healthy volunteers aged 55 years and older than the two treatment arms (5 mg and 10 mg lemborexant). In this study, the only adverse event observed in two or more people in the lemborexant group was headache.
Dr. Russell Rosenberg, principal investigator of the clinical trial and former chairman of the National Sleep Foundation, said: "As a clinician and researcher who has been treating sleep disorders for 30 years, successful insomnia treatment means they can sleep well. I can wake up well and have no physical damage. It is important for me not only to explain that the drug can help the patient fall asleep, but also to explain any potential risks, such as the damage the next morning. Especially important, for them, the ability to wake up undamaged remains a constant problem."
These studies are based on a growing body of knowledge about lconrexant. Including another recently completed clinical phase 1 study, Study106, which evaluated the residual effects of the next morning through a driving test, which also met its primary goal. This study was compared to placebo and pyrazolidine was used as a positive control to assess potential damage the next morning by measuring the driving ability of adult and elderly participants. In this study, the most common AEs in the lemborexant group were lethargy and headache. Eisai and Purdue Pharmaceuticals also plan to announce the results at the upcoming 32nd Professional Sleep Association Annual Meeting.
Lemborexant appears to affect a potential cause of poor sleep in patients, acting on the orexin neurotransmitter system and is thought to regulate sleep and wake up by controlling arousal without impeding the ability to be awakened by external stimuli.
Dr. Lynn Kramer, Chief Medical Officer and Chief Clinical Officer of Eisai Neuroscience, said: "The treatment of sleep disorders is expected to provide sleep and wakefulness treatment for patients with sleep disorders, which can improve their sleep ability all night. But if they wake up at night or wake up in the morning, they can work as well. Eisai and Purduu scientists know that especially elderly patients are not satisfied with the risk of falls and motor vehicle collisions, so they have been Seeking to find better medicines for treating sleep disorders."
Lemborexant was discovered by Eisai Pharmaceuticals and developed in collaboration with Purdue. In addition to the above clinical trials, trials currently underway include treatment studies for sleep-wake rhythm disorder (ISWRD) in Alzheimer's patients. (Sina Pharmaceutical Compilation / David)
Article Reference Source: EISAI AND PURDUE PHARMA ANNOUNCE POSITIVE TOPLINE RESULTS FROM KEY CLINICAL STUDIES OF LEMBOREXANTINCLUDING FIRST-EVER PHASE 3 HEAD-TO-HEAD SUPERIORITY COMPARISON VERSUS ZOLPIDEM ER IN PATIENTS WITH SLEEP DISORDER
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