Eisai said that SEP-190 is a non-benzodiazepine type GABAA agonist (non-benzodiazepine sedative hypnotic) that is effective in treating transient and chronic insomnia and that can be used over the long-term without patients developing a tolerance resistance to it.
The MAA is supported primarily on two pivotal clinical studies conducted with SEP-190 in Japan, namely a Phase II/III (Study 126) clinical study in patients with primary insomnia and a Phase III study (Study 150) in patients with insomnia.
Study 126 demonstrated that, compared to placebo, SEP-190 reduced latency to persistent sleep (LPS), as measured by an overnight polysomnography (PSG), and sleep latency (SL), as measured by subjective evaluation, in adult Japanese patients with primary insomnia.
Eisai claimed that the study 150 confirmed the favorable long-term safety profile of the agent in adult and elderly Japanese insomnia patients.