Please login to the form below

Not currently logged in
Email:
Password:

Aricept patch filed with FDA

The US FDA has accepted for review a New Drug Application for a patch version of Eisai's blockbuster Alzheimer's disease drug Aricept

The US Food and Drug Administration (FDA) has accepted for review a New Drug Application (NDA) for a patch version of Eisai's blockbuster Alzheimer's disease drug Aricept (donepezil).

The filing comes as the oral formulation of the drug is facing patent expiry.  Eisai said earlier this year that it expects annual US sales of Aricept to plummet from $2bn to $800m by 2013 because of the introduction of generic competition.

The transdermal product, which is expected to improve patient compliance, will be co-promoted by Eisai and Pfizer if it is approved in the US. Pfizer already co-promotes the oral version of the drug in the US.

The weekly patch was developed through a partnership between Eisai and Teikoku Pharma USA, a subsidiary of Japan's Teikoku Seiyaku that specialises in developing transdermal formulation of medicines.

The NDA, which was submitted on June 30, seeks approval of the patch for mild, moderate and severe stages of Alzheimer's disease. The oral formulation of Aricept, which is sold as regular tablets and disintegrating tablets, must be taken every day. It is the only drug currently approved by the FDA for all three stages of the disease.

Earlier this year, the FDA approved a high-dose, 23mg formulation of the oral drug, which was previously available only in 5mg and 10mg tablets. The high-dose product has three years of marketing exclusivity.

If the patch version of the drug is cleared for marketing, it will compete with Novartis' Exelon Patch, which is approved for mild to moderate Alzheimer's disease, as well as mild to moderate Parkinson's disease dementia. The Novartis patch was cleared by the FDA in 2007 as the first transdermal drug for Alzheimer's disease.

20th September 2010

Share

Subscribe to our email news alerts

Featured jobs

PMHub

Add my company
Innovative Trials

Innovative Trials is a leading global clinical trial patient recruitment company. With over 10 years’ experience, Innovative Trials deploys “boots-on-the-ground”...

Latest intelligence

Flu
Influenza – the risk to vulnerable populations
Why we can't get complacent about flu vaccination...
dementia
Alzheimer’s Research UK highlights socio-economic inequalities in dementia risk
The charity aims to improve the number of women participating in dementia research and grow awareness of dementia risk factors...
Data security
Concerns about data security are building a strong case for clinical mobility in EMEA
Electronic medical records have transformed the storage of sensitive information but how can the healthcare sector continue to protect patient and staff data?...