New Aricept Doses Approved by FDA

by Mahesh on July 30, 2010

Eisai and Pfizer announce FDA approval of increased doses of Aricept, their popular acetlycholinesterase inhibitor given to patients with Alzheimer’s disease.

FDA grants approval to 23 mg/day Aricept pill

Aricept (donepezil HCl), is a prescription medicine used  to treat the three stages (mild, moderate and severe) of Alzheimer’s disease. Based on the FDA announcement, patients suffering from mild Alzheimer’s can continue to take the conventional lower dose (up to 10 mg/day), while those suffering from  moderate to severe Alzheimer’s can take the new dose of up to 23 mg/day. Aricept alleviates the symptoms of Alzheimer’s – and (although not proven) there have been some reports of improvement in cognition and behavior.

According to an article in Canadian Business Online, this drug has brought Pfizer $432 million in 2009 and Eisai a huge $3.3 billion, making it the largest seller of the four drugs that can temporarily reduce Alzheimer’s symptoms.

While the struggle to find a more effective treatment for Alzheimer continues, Aricept is Pfizer’s and Eisai’s leading drug in the neurological disease pipeline. Pfizer has been smart enough to maintain Eisai’s alliance on this product, especially after the relationship was in question with the Pfizer-Wyeth merger.

The FDA approval came as a result of a study of 1,467 patients with moderate to severe Alzheimer’s who were tested after both dosage levels (10mg/day and 23 mg/day).  Patients are generally started on a much lower dose of 5 mg/day before ramping up to 10 mg/day after 4-6 weeks. The higher dose of the drug is only available to patients who have been taking Aricept’s lower dose of 10 mg/day for at least 3 months.

Higher dose Aricept could provide more relief to patients

According to the Alzheimer’s Association, approximately 5.3 million Americans suffer from Alzheimer’s disease in the United States. This leads to an annual cost of 172 billion dollars to manage the disease. Although these dose changes do not come with any guarantee, the goal is to provide additional symptomatic relief to patients. In the meantime, we all look forward to future treatments that could promise a better life for those suffering from this disease.

We have reviewed some of the treatment options available to Alzheimer’s patients in a previous post here .

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