Are TV Advertisements for Aricept Misleading?

Contributed by: Dennis Fortier, President, Medical Care Corporation
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According to the FDA, they are.

Aricept is the most commonly prescribed treatment for Alzheimer's disease. It is indicated for treatment of mild to moderate dementia of the Alzheimer's type and data from FDA clinical trials suggests that it is more effective in relieving symptoms than in delaying the underlying disease.

However, recent television advertisements sponsored by Eisai (manufacturer of the drug) and Pfizer (US distributor of the drug) depict adults first meeting with a doctor, accompanied by an apparent caregiver, and then later engaged in daily activities such as gardening and caring for pets. In the opinion of the FDA, these ads suggest a level of improvement that is not supported by clinical data. The ads are currently suspended while the companies respond to the FDA's complaint.

Whatever the outcome, it is important to understand the treatment efficacy of cholinesterase inhibitors (the class of drugs to which Aricept belongs). Data from the FDA clinical trials suggest a symptomatic benefit and ongoing analysis of those data indicate a small but discernible disease delaying effect for some patients, especially those who begin treatment at an early stage of the disease. Importantly, it is now well established that a cholinesterase inhibitor combined with Namenda (a partial glutamate antagonist) yields the most benefit over the longest treatment period.

Aricept to be Available in New Formulations?

Contributed by: Dennis Fortier, President, Medical Care Corporation
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Eisai, Inc., makers of the most widely prescribed Alzheimer's medication (Aricept), released a status update today on two studies they have sponsored. The indications are that they expect to bring two new formulations of Aricept to the market in the future.

First, they have concluded a successful review of phase III data on a sustained release capsule that could improve clinical outcomes by mediating the dose of the drug in the bloodstream. The company announced an intention to file and NDA (New Drug Application) with the FDA by end of summer 2009.

Eisai also announced that they are studying a transdermal patch formulation at locations in Japan and the USA. Their expectation is that an NDA for this formulation might be filed within the next 12 months.

The FDA pipeline for new Alzheimer's treatments is quite full but it is encouraging to see that those drugs already approved are also being optimized through ongoing research and development.