Eisai Aricept tablets accepted for FDA review

Eisai’s Aricept tablets have been accepted for review by the Food and Drug Administration (FDA), it has revealed.

The firm revealed that its new drug application (NDA) will now be reviewed for Aricept 23 mg (donepezil hydrochloride) – an Alzheimer’s disease (AD) treatment in the form of extended-release tablets.

This is a higher measure than the 10 mg dose previously submitted for review to the FDA and is intended to treat those with moderate to severe AD.

Eisai’s new NDA is based on the results of a phase III trial, which compared the effects of 23 mg of Aricept immediate-release tablets with 10 mg doses.

Aricept, which is currently approved in around 90 countries, is an acetylcholinesterase inhibitor that increases brain levels of the neurotransmitter acetylcholine by inhibiting breakdown.

Last week, Eisai launched its latest therapy – the Lusedra (fospropofol disodium) injection, a drug that is designed for use in patients requiring treatment with a intravenous sedative-hynotic agent.