Eisai Announces Positive Phase III Trial Results for Perampanel in Epilepsy

Update: Fycompa (perampanel) Now FDA Approved - October 22, 2012

WOODCLIFF LAKE, N.J.--(BUSINESS WIRE)--Aug 24, 2010 - Eisai Inc. announced today the results of a Phase III study for the investigational compound perampanel (E2007), a first-in-class, highly selective non-competitive AMPA-type glutamate receptor antagonist, discovered by Eisai and being developed for treatment of partial seizures in patients with epilepsy.

The double-blind, placebo-controlled, parallel-group study (Study 306) showed that perampanel was well-tolerated and effective in reducing median seizure frequency and increasing responder rates, the primary outcome measures in the United States and European Union, respectively. The findings were highly statistically significant in 4 mg and 8 mg doses compared to placebo. A linear trend for dose response was also statistically significant.

The global study consisted of 706 patients from 25 countries who were randomized to placebo or one of three perampanel doses. Patients started on 2 mg doses of perampanel, then remained on 2 mg or increased dosage weekly in 2 mg increments to their randomized doses of 4 mg or 8 mg. The most common adverse events reported were dizziness, somnolence and headache.

Study 306 is the first in a series of Phase III clinical trials as part of Eisai's development program for perampanel and two more global Phase III studies are underway. Eisai plans to submit the studies as part of global applications, and results are expected to be available within one year.

As previously announced, Eisai intends to submit simultaneously in the United States and European Union in our Fiscal Year 2011 (year ending March 31, 2012).

About Eisai Inc.

Eisai Inc. was established in 1995 and is ranked among the top-20 U.S. pharmaceutical companies (based on retail sales). The company began marketing its first product in the United States in 1997 and has rapidly grown to become a fully integrated pharmaceutical business with fiscal year 2009 (year ended March 31, 2010) sales of approximately $3.9 billion. Eisai's areas of commercial focus include neurology, gastrointestinal disorders and oncology/critical care. The company serves as the U.S. pharmaceutical operation of Eisai Co., Ltd.

Eisai has a global product creation organization that includes U.S.-based R&D facilities in Maryland, Massachusetts, New Jersey, North Carolina and Pennsylvania as well as manufacturing facilities in Maryland and North Carolina. The company's areas of R&D focus include neuroscience; oncology; vascular, inflammatory and immunological reaction; and antibody-based programs. For more information about Eisai, please visit www.eisai.com.

About Eisai Co., Ltd.

Eisai Co., Ltd. is a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Through a global network of research facilities, manufacturing sites and marketing subsidiaries, Eisai actively participates in all aspects of the worldwide healthcare system. Eisai employs approximately 11,000 employees worldwide.

Contact: Eisai Inc.
Media Inquiries
Judee Shuler, 201-746-2241
or
Investor Inquiries
David Melin, 908-255-6378

 

 

Posted: August 2010

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