The FDA authorises Eisai’s DAYVIGO insomnia medicine

Eisai’s DAYVIGO (lemborexant) drug, for the treatment of sleep onset/maintenance insomnia in adults, has been authorised by the US Food and Drug Administration (FDA), following the results of 2 pivotal phase 3 studies, part of a clinical development programme, which revealed that DAYVIGO provided exceptional advantages compared to the given placebo. Approximately two-thousand people with insomnia volunteered to take part in the studies, where DAYVIGO’s effects were compared with a placebo for 6 months and comparators for up to 1 month.

The FDA has suggested that the drug should be classified as a controlled substance, and at the present time, Eisai is awaiting for the Drug Enforcement Agency’s (DEA) approval so that it can become commercially available.

Former chairman of the Board of the National Sleep Foundation & a Principal Investigator in the DAYVIGO clinical studies, Russell Rosenberg, PhD, stated: “Insomnia disorder is a chronic condition that has a variety of potential negative impacts and long term consequences for health and wellbeing. The clinical trials provide evidence that DAYVIGO may improve patients’ ability to fall asleep and stay asleep.”

Chief Clinical Officer and MD of Neurology Business Group at Eisai, Lynn Kramer, stated: “We believe the approval of DAYVIGO is particularly exciting because it is the first FDA approved medication to report safety data over a twelve month period along with sleep onset and sleep maintenance efficacy data over a six-month period in a pivotal clinical study. We look forward to making this new therapeutic option available to the millions of patients who suffer with insomnia.