Eisai to delay E2007 filing until fiscal 2008

Japanese drugmaker Eisai is to delay filing its developmental alpha-amino-3-hydroxy-5-methyl-4-isoxazole propionic acid receptor antagonist E2007 (perampanel) until the fourth quarter of its fiscal year 2008. The firm, which had originally intended to submit E2007 to both the US Food and Drug Administration and the European Medicnes Agency (EMEA) in the current financial year, said that the decision follows the drug's failure to show a significant difference to placebo in treating symptoms of Parkinson's disease in a recently-completed Phase III trial.

Preclinial assessment of E2007 indicated that it prolonged both levodopa's duration of action and the time for which symptoms were improved Additionally, a Phase II proof-of-concept study suggested that the drug reduced the "off" time, that is the period when disease symptoms return as dopamine's therapeutic benefits begin to wear off, in a dose dependant manner.

However, current analysis of data from the first of three Phase III trials suggests that E2007's therapeutic benefit is not superior to placebo. Despite this, Eisai said that it intends to use the findings to plan the analysis of two ongoing Phase III assessments in an effort to clarify the agent's efficacy and safety profile. The Tokyo-headquartered firm added that it is also examining the drug in other indications, including neuropathic pain and epilepsy, for which it plans to make regulatory submissions in its 2010 fiscal year.