HATFIELD, England, August 24, 2010 /PRNewswire/ -- Eisai today announced 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 under development for adjunctive 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 versus placebo, the primary outcome measures in the U.S. and the E.U., respectively. The findings were 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 for adjunctive therapy in partial seizures 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 U.S. and E.U. in our Fiscal Year 2011.
About Eisai Europe in Epilepsy
Eisai is committed to making further contributions to addressing the diversified needs and improving quality of life of patients with epilepsy. Eisai has three currently marketed treatments in Europe, these are:
- Zonegran(R) as adjunctive therapy in adult patients with partial-onset seizures, with or without secondary generalisation - Zebinix(R) (eslicarbazepine acetate) (under license from Bial - Portela Ca, S.A in Europe) as adjunctive therapy in adult patients with partial-onset seizures, with or without secondary generalisation - Inovelon(R) for the treatment of seizures associated with Lennox-Gastaut Syndrome
Eisai is one of the worlds leading RD-based pharmaceutical companies and has defined its corporate mission as giving first thought to patients and their families and to increasing the benefits health care provides, which we call human health care (hhc).
Eisai concentrates its RD activities in three key areas:
- Integrative Neuroscience, including: Alzheimer's disease, multiple sclerosis, neuropathic pain, epilepsy, depression - Integrative Oncology including: anticancer therapies; tumor regression, tumor suppression, antibodies, etc and supportive cancer therapies; pain relief, nausea - Vascular/Immunological reaction including: acute coronary syndrome, atherothrombotic disease, severe sepsis, rheumatoid arthritis, psoriasis, Crohn's disease
With operations in the U.S., Asia, Europe and its domestic home market of Japan, we employ more than 11,000 people worldwide.
In Europe, Eisai undertakes sales and marketing operations in over 20 markets, including the United Kingdom, France, Germany, Italy, Spain, Switzerland, Sweden, Ireland, Austria, Denmark, Finland, Norway, Portugal, Iceland, Czech Republic, Hungary, and Slovakia.
For further information please visit our web site http://www.eisai.co.jp
SOURCE: Eisai Europe Ltd.
CONTACT: Media Inquiries: Cressida Robson, Eisai Europe Ltd.,firstname.lastname@example.org , +44-7908-314-155.