September 15, 2010 - EISAI PLANS TO SUBMIT MAA IN FISCAL 2010 - Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito, “Eisai”) announced that clinical studies conducted in Japanese patients with insomnia have confirmed the efficacy and favorable safety profile of SEP-190 (generic name: eszopiclone). Based on these results, Eisai plans to submit a marketing authorization application in fiscal 2010 seeking approval of the agent to the Japan’s Ministry of Health, Labour and Welfare.A Phase II/III clinical study (Study 126) with SEP-190 was conducted in Japan in patients with primary insomnia, in addition to a Phase III study (Study 150) in patients with insomnia. Study 126 evaluated the efficacy of SEP-190 in 72 adult patients with primary insomnia through an overnight polysomnography (PSG) and subjective evaluation. Results showed that, compared with placebo, SEP-190 statistically significantly reduced latency to persistent sleep (LPS), as measured by a PSG, and sleep latency (SL), as measured by subjective evaluation, the study’s two primary outcome measures. Study 150 evaluated the long term safety of SEP-190 in 325 adult and elderly patients with chronic insomnia caused by a variety of factors. Results of the study confirmed that the agent has a favorable safety profile.
SEP-190 is a non-benzodiazepine type GABAA agonist (non-benzodiazepine sedative hypnotic) discovered and developed by Sepracor Inc.,... Eisai's Press Release -
