Eisai Inc. and Pfizer Inc announced today that the U.S. Food and Drug Administration (FDA) has accepted for review Eisai's New Drug Application (NDA) for once daily 23 mg Aricept® (donepezil HCl extended release) tablets for the treatment of moderate to severe Alzheimer's disease (AD).
The details can be read here.
3 comments:
Am I missing something. The 10mg Aricept is once a day already. Is this a new idea for evergreening. Take a once a day product...say 10mg and reformulate it to release only half the active so you need to give 20mg! Where is the clinical advantage?
The advantage is in the lesser side effects due to lesser plasma level fluctuations due to Immediate release dosage form.
This is my opinion and shoudl not be construed as legal opinion or promotional matter.
The 10mg tablets are meant for mild-to-moderate Alzheimer's. This new, higher dose tablet is meant for more advanced, moderate-to-severe Alzheimer's. You can read about on AlzWeek.com. The article is called,
Generic Aricept Approved, Disolves in Mouth.
Also, FDA Reviews Extended-Release Aricept.
I would also venture a guess that since the lower dose has its bag of side-effects, they needed some way to ease that in the higher dose. It's more than double the dose, so unless it was put in an extende-release pill, it would have more than double the side-effects. Don't know that for sure, but it seems like common sense.
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