Eisai and Purdue Pharma have announced six-month results from the SUNRISE 2 Phase III clinical study evaluating the efficacy and safety of lemborexant.
The drug is under development for the treatment of insomnia, evaluated in a 12-month multicenter, global, randomised, controlled, double-blind, parallel-group study of 949 adult patients of 18 to 88 years of age who suffer from insomnia.
The six-month data showed significant improvements in patient-reported measures of sleep onset and sleep maintenance for the treatment.
The results showed a statistically significant improvement compared to placebo in patient-reported sleep onset latency (sSOL), the study’s primary efficacy endpoint. it also showed improvements in subjective sleep efficiency (sSE) and subjective wake after sleep onset (sWASO), the study’s key secondary endpoints.
“These findings add to the growing body of clinical data supporting the development of lemborexant for the treatment of insomnia, and we look forward to presenting 12-month results from the study in a future scientific forum,” said Lynn Kramer, MD, chief clinical officer and chief medical officer, Neurology Business Group, Eisai.
She continued, “It remains our aspiration to bring a medicine to physicians and patients that helps patients sleep well at night and wake well in the morning.”
The study supported the New Drug Application for lemborexant for the treatment of insomnia, filed with the US Food and Drug Administration on December 27 last year. In Japan, an application is scheduled to be filed within fiscal 2018.
Lemborexant acts on the orexin neurotransmitter system and is believed to regulate sleep and wake by dampening wakefulness without impeding the ability to awaken to external stimuli.