FDA clears Aricept 23 mg tablet for Alzheimer’s treatment
POSTED July 25, 2010 - 15:05 | POSTED BY Neharika Sabharwal
Last edited by Harpreet Bhagrath on July 25, 2010 - 15:55
Aricept is the only prescription drug approved by the health regulators to help stave off the mental problems tied to all stages of AD—mild, moderate, and severe dementia.
Though it is not a cure for the disease, Aricept may be effective in reducing symptoms and stabilizing, and also arresting, the progression of the disease in those already established on a regimen of lower dose.
Aricept, currently available in 5 mg tablet, 10 mg tablet, and orally disintegrating tablet (5 mg and 10 mg), will soon be available in 23 mg tablet in U.S. pharmacies.
Study details
The approval for the higher dose of Aricept was granted on the basis of a head-to-head, double-blind, placebo-controlled, parallel-group clinical study involving 1,467 patients with moderate-to-severe AD.
All the patients had used Aricept 10 mg tablet for three months or more.
In order to assess the benefits of the higher dose on cognitive function, the researchers compared Aricept 23 mg tablet with Aricept 10 mg tablet.
Revelations of the study
Though the higher dose of Aricept did not achieve any significant progress in global function, there was a marked improvement in cognition.
The only adverse events were nausea, vomiting, diarrhea, and anorexia due to Aricept 23 mg tablet.
Lead author of the study, Dr. Martin R. Farlow, professor and vice-chairman of research, department of neurology, Indiana University School of Medicine stated, “Slowing the decline of cognitive symptoms is important at all stages of Alzheimer’s disease.
“Throughout the course of AD, caregivers are usually the first to notice changes in cognition. It’s important for families to talk with their doctor when they notice a worsening in cognitive function in their loved ones to reevaluate therapeutic needs.”
About Alzheimer’s
Alzheimer's is a degenerative neurological disease that seriously affects a person's ability to carry out daily activities.
It involves the parts of the brain that control thought, memory, and language. It begins with temporary loss of memory, but with time, symptoms get worse.
People afflicted with the disease may have trouble remembering things, may not recognize family members, or have trouble speaking, reading, or writing.
Over time they may become anxious or aggressive, or wander away from home. Eventually, they need constant care.
Alzheimer usually strikes after 60 years, but the risk increases with age. There is no treatment available to stem the disease.
However, some drugs may help keep symptoms from getting worse for a limited time.
