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Replies to post #247891 on Anavex Life Sciences Corp (AVXL)
INTRODUCTION
Alzheimer’s disease (AD), a devastating neurodegenerative disorder, is the leading cause of dementia in the U.S. and in other developed countries. Patients experience progressive, disabling cognitive impairment and eventually require constant care and supervision. Approximately 96% of AD patients are elderly, but the absolute number of patients younger than 65 years of age has grown with the arrival of the “baby-boomer” generation (those born between 1946 and 1964) to the cusp of old age.1
AD is the sixth leading cause of death for all ages and the fifth leading cause of death for those 65 years of age and older in the U.S.1,2 This disorder affects approximately 5% of people 65 to 74 years of age and almost 50% of people older than 85 years of age, at an annual cost of approximately $148 billion in the U.S. alone.1 The problem will become much greater as baby-boomers age. An estimated 5.3 million persons in the U.S. have AD. This figure is projected to grow to 13.2 million by 2050.1
Given the impact of AD, there is an urgent need for effective therapies. Currently, five drugs have been approved by the FDA for use in AD, including four cholinesterase inhibitors and one N-methyl-d-aspartate (NMDA) receptor antagonist (see Drug Therapy). The five medications are widely utilized, and several respected organizations have endorsed their use.3 As of this writing, no alternatives to these medications are available. These five drugs are supportive or palliative rather than curative or disease-modifying therapies, and they do not appear to alter the final outcome of the disease.3 The total dollars expended on these treatments in the U.S. alone exceeds $1 billion annually, and these therapies continue to be heavily promoted by their respective manufacturers.4 Nevertheless, the ongoing debate over their effectiveness continues, especially in view of the costs incurred.5
In this article, we review the evidence supporting the use of these agents and explore the controversies involved. This discussion is timely in view of the national debate on health care reform, because it involves the need to balance costs and benefits on an enormous scale. Similar debates may be expected in many other areas of medicine.
Donepezil, sold as the trade name Aricept among others, is a medication used to treat Alzheimer's disease.[4] It appears to result in a small benefit in mental function and ability to function.[5] Use, however, has not been shown to change the progression of the disease.[6] Treatment should be stopped if no benefit is seen.[7] It is taken by mouth.[4]
Common side effects include nausea, trouble sleeping, aggression, diarrhea, feeling tired, and muscle cramps.[4][7] Serious side effects may include abnormal heart rhythms, difficulty emptying urine from the bladder, and seizures.[4] Donepezil is a centrally acting reversible acetylcholinesterase inhibitor and structurally unrelated to other anticholinesterase agents.[4][1]
Donepezil was approved for medical use in the United States in 1996.[4] It is available as a generic medication.[7] In the United Kingdom a typical month's supply costs the NHS about £0.52 as of 2019.[8] The wholesale cost of this amount in the United States is about US$1.38.[9] In 2017, it was the 127th most commonly prescribed medication in the United States, with more than five million prescriptions.[10][11]
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Alzheimer's disease
There is no evidence that donepezil or other similar agents alters the course or progression of Alzheimer's disease. Six-to-twelve-month controlled studies have shown modest benefits in cognition or behavior.[12] The UK National Institute for Clinical Excellence (NICE) recommends donepezil as an option in the management of mild to moderate Alzheimer's disease.[13] The person should, however, be reviewed frequently and if there is no significant benefit it should be stopped.[13] In 2006 the U.S. Food and Drug Administration also approved donepezil for treatment of mild, moderate and severe dementia in Alzheimer's disease.[14]
