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FDA Accepts Aricept Patch (Donepezil Transdermal System) NDA For Review Also Included In: Regulatory Affairs / Drug Approvals; Pharma Industry / Biotech IndustryTeikoku Pharma USA, Inc., an international specialty pharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for a new weekly transdermal patch of Aricept , a leading medication for the treatment of Alzheimer's disease.Donepezil in Alzheimer�s disease: an evidence-based review of itReal benefits for authors, including fast-track processing of papers. Donepezil is indicated for the symptomatic treatment of mild to moderate Alzheimer s disease. It is a specific and reversible inhibitor of acetylcholinesterase (AChE); by increasing levels of available acetylcholine, donepezil may compensate for the loss of functioning cholinergic brain cells. There is strong evidence that donepezil has efficacy against the three major domains of Alzheimer s disease symptoms, namely functional ability, behavior, and cognition. The strongest evidence is for improvement or less deterioration in global outcomes and cognition in the short to medium term. There is limited evidence that improved global outcomes are maintained in the long term and clear evidence to support long-term maintenance of cognitive benefits. Also, donepezil appears to maintain function in the long term and there is some level 1 and 2 evidence of improved or limited deterioration in behavior or mood in the short to medium term. Despite donepezil s effects on major symptoms of Alzheimer s disease, its impact on patients quality of life has not been consistently demonstrated, perhaps reflecting the difficulty of assessing this aspect in this patient population. Donepezil may also lessen caregiver burden. Donepezil has some effect on markers of brain function, but more data are needed to confirm a neuroprotective effect. There is limited and conflicting evidence that long-term donepezil treatment delays time to institutionalization. There is some evidence that donepezil may be cost effective, especially when unpaid caregiver costs are considered. Donepezil is generally safe and well tolerated.Donepezil: A Review of Pharmacological Characteristics and Role in the Donepezil: A Review of Pharmacological Characteristics and Role in the Management of Alzheimer DiseaseDonepezil is a potent, selective, noncompetitive, and rapidly reversible inhibitor of acetylcholinesterase (AChEI) licensed for the treatment of Alzheimer disease (AD); and is the first and only AChEI licensed for the treatment of severe AD. Its efficacy as monotherapy, or in combination with the NMDA-agonist, memantine, has been documented in several randomised double-blind, placebo-controlled, short-term clinical trials, as well as long-term extension trials and observational studies. Donepezil is a well tolerated drug that is generally safe as demonstrated even in patients with multiple co-morbidities receiving polypharmacy. It has been shown that donepezil improves cognition and global function in patients with mild-to-moderate AD; and long-term efficacy is maintained for up to 50 weeks. There is a dose-response relationship, with higher doses more likely to produce symptomatic benefit. Furthermore, donepezil- treated patients may improve cognitively and show global clinical improvement in all disease stages, including severe AD.
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