Marketing Authorization Application for Dual Orexin Receptor Antagonist Lemborexant Submitted in Japan for Insomnia Disorder

March 08, 2019/BioValleyBIOON/-- Japanese pharmaceutical company Eisai recently announced that it has submitted a marketing authorization application for lemborexant in Japan, seeking approval for the treatment of insomnia disorder, a sleep-wake disorder. In late December last year, Eisai and its partner Purdue Pharma submitted the application to the U.S. Food and Drug Administration (FDA) submitted a New Drug Application for lemborexant.

This application is based on the results of two pivotal Phase III clinical studies, SUNRISE-1 (Study 304) and SUNRISE-2 (Study 303), which evaluated lemborexant for the treatment of patients with insomnia, as well as important safety studies, including assessments of postural stability after nighttime awakenings and a next-day driving study (Studies 106 and 108). SUNRISE-1 and SUNRISE-2 enrolled approximately 2,000 patients in total. SUNRISE-1 was conducted in patients aged ≥55 years with difficulty initiating sleep, evaluating the efficacy and safety of lemborexant compared with placebo and the active control zolpidem tartrate extended-release. The data demonstrated that the study met its primary and secondary endpoints. SUNRISE-2 was conducted in more than 900 adult patients (aged 18–88 years) with insomnia, evaluating the efficacy and safety of lemborexant compared with placebo. The data demonstrated that this study also met its primary and key secondary endpoints.

Molecular structure of lemborexant (Image source: Wikipedia)

Lemborexant is a dual orexin receptor OX1 and OX2 antagonist discovered and developed internally by Eisai. This compound inhibits orexin by competitively binding to the two subtypes of orexin receptors (orexin receptor 1 and receptor 2). In individuals with insomnia disorder, the orexin system, which regulates sleep and wakefulness, may not function properly. During normal sleep cycles, activity of the orexin system is suppressed; this suggests that lemborexant may promote the initiation and maintenance of sleep by intentionally interfering with orexinergic neurotransmission.

Currently, Eisai is collaborating with Purdue Pharma to develop lemborexant for the treatment of various sleep disorders. Among these efforts, a Phase II clinical study is evaluating the efficacy and safety of lemborexant in patients with irregular sleep-wake rhythm disorder (ISWRD) and mild-to-moderate Alzheimer’s disease (AD). (Bioon.com)

Original Source:MARKETING AUTHORIZATION APPLICATION FOR POTENTIAL INSOMNIA DISORDER TREATMENT LEMBOREXANT SUBMITTED IN JAPAN