Eisai and Purdue reveal positive Phase 3 data in insomnia
pharmafile | February 7, 2019 | News story | Research and Development | Eisai, Purdue Pharma, insomnia, lemborexant, pharma
Partners Eisai and Purdue Pharma have lifted the curtain on Phase 3 clinical data on their jointly developed therapy lemborexant in the treatment of insomnia.
The data, derived from 949 adults (28% of which were over 50), revealed that, after six months receiving either 5 or 10mg, patients experienced “significant improvements” in patient-reported sleep onset latency (sSOL), meeting the trial’s primary endpoint. Specifically, the 5mg group saw median improvements of 21.81 minutes and the 10mg saw a median reduction of 28.21 minutes, compared to 11.43 with placebo.
The therapy also met its secondary endpoints of improvements in subjective sleep efficiency (sSE) and subjective wake after sleep onset (sWASO).
“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. “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 six-month findings from SUNRISE 2 are exciting, highlighting improvements in subjective measures of both sleep onset and sleep maintenance,” said John Renger, PhD, Head of Research & Development and Regulatory Affairs, Purdue Pharma. “SUNRISE 2 was a robust Phase 3 clinical study in which the self-reported patient outcomes are encouraging as they reflect the patients’ perception of lemborexant’s impact on enabling the patient to both fall asleep faster and stay asleep longer.”
Matt Fellows
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