FDA accepts new drug application for Lemborexant to treat insomnia

Recently, Japanese drugmaker Eisai and Purduepharmaceutical(http://
(http://imbrium Therapeutics announced that the u.SFood andDrug http://(
FDA)administration (http://has accepted theof a new drug for the treatment of insomnia, a sleep-wake disorder
http://application (NDA) and has designated a target date for the Prescription Drug User Charge (PDUFA) as December 27, 2019The NDA submission is based on data from a clinical development project to evaluate lemborexant's treatment of insomnia, including two critical Phase III clinical studies SUNRISE-1 (304 studies) and SUNRISE-2 (303 studies) in a group of approximately 2,000 patientsThe SUNRISE-1 study, conducted in 1006 patients aged 55 years (45 percent of patients aged 65 years) and sleep-less at night, assessed the efficacy and safety of lemborexant relative to placebo and the positive-control drug tattsoftatonos, and data showed that the study reached the primary and secondary endpoints, with the most common adverse events reported in the Lemborexant treatment group being headache and drowsinessThe SUNRISE-2 study, conducted in 949 adults (18-88 years) of insomnia, assessed the efficacy and safety of lemborexant relative to placebo, and the data showed that the study also reached major and critical secondary endpointsThe most common adverse events reported by the lemborexant treatment group were drowsiness, nasopharyngitis, headache and influenzaabout lemborexantlemborexant is a dual inhibitor of the psynoson receptor OX1 and OX2, found and developed internally by the secrobios, the compound is competitively combined with 2-bell subtypes of appetite receptors (psynoson receptors 1 and receptor 2) to suppress appetiteIn individuals with insomnia disorders, the appetite-insin system that regulates sleep and wakefulness may not function properlyDuring the normal sleep cycle, the activity of the appetite-intelline system is inhibited; this reveals that the ability to interfere with the neurotransmission of appetite through lemborexant is intended to promote the initiation and maintenance of sleepCurrently, Wesfarmers is working with Imbrium Therapeutics to develop lemborexant for the treatment of a variety of sleep disordersAmong them, a Phase II clinical study is evaluating the efficacy and safety of lemborexant in treating patients with wakeful rhythm disorder (ISWRD) and mild to moderate Alzheimer's disease (AD)