Eisai submits application in Japan for new formulation of Aricept

Published: 14-Dec-2011
Regulatory Mental Health Cognitive

Seeks approval for new dry syrup formulation of Alzheimer’s disease treatment


Eisai has submitted a marketing and manufacturing authorisation application to Japan's Ministry of Health, Labour and Welfare seeking approval of a new dry syrup formulation of its Alzheimer's disease treatment Aricept (donepezil hydrochloride).

In August 2007, the indication of Aricept was expanded to include severe Alzheimer’s disease. The simultaneous approval of additional daily dosage to a maximum of 10mg also made it possible to adjust Aricept dosage amounts.

This latest version of Aricept is a dry syrup formulation that can be administered by suspending dry syrup powder with water, which allows dosage to be adjusted within approved dosage amounts at the time of administration depending on the needs of individual patients. It was designed as a suspension to make it easier for patients who find powder too dry or bulky to swallow, and so that it can be taken with water in the same way as the existing Aricept fine granules formulation. These features are expected to improve drug compliance.

Aricept, discovered and developed by Eisai, is an acetylcholinesterase inhibitor that contains donepezil hydrochloride as its main ingredient, and is the only prescription medicine approved in Japan for the treatment of all stages of Alzheimer’s disease.

The company is also conducting two clinical development projects for Aricept in Japan with the aim of obtaining approval for its use in the treatment of dementia with Lewy bodies (Phase III) as well as a new 23mg tablet (Phase II).
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