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The U.S. Food and Drug Administration Approves Exelon(R) (rivastigmine tartrate) as the First Medication Indicated to Treat Parkinson's Disease Dementia - An estimated 40% of Parkinson's disease patients develop dementia - The risk of developing dementia is approximately four to six times higher among Parkinson's patients than among elderly people without the disease EAST HANOVER, NJ -- June 28, 2006 -- Novartis Pharmaceuticals Corporation announced today that the U.S. Food and Drug Administration (FDA) has approved Exelon (rivastigmine tartrate) for the treatment of mild to moderate Parkinson's disease dementia, making Exelon the first medication available for the treatment of this condition. Exelon is also indicated for the treatment of mild to moderate Alzheimer's disease. According to the National Parkinson Foundation (NPF), Parkinson's disease affects 1.5 million Americans. Approximately 40% of patients with Parkinson's disease are estimated to also develop dementia, which can have a devastating effect on patients and their families. The risk for developing dementia among Parkinson's patients is approximately four to six times higher than among elderly people without this disease. According to the NPF, dementia is one of the complications most feared by Parkinson's disease patients and their caregivers. "Parkinson's disease dementia takes a significant emotional, economic and social toll on patients and their families," said Laura Marsh, MD, Director, Clinical Research Program Johns Hopkins Morris K. Udall Parkinson's Disease Research Center and member of the American Parkinson Disease Association Scientific Advisory Board. "With current Parkinson's disease treatments, we are often able to manage the movement symptoms of the disease, but there has been a significant gap in our ability to treat dementia in these patients, which is why this approval is such a welcome development." The approval of Exelon for the treatment of Parkinson's disease dementia follows a unanimous recommendation in favor of approval from the FDA's Peripheral and Central Nervous System Drugs Advisory Committee on May 17, 2006, which was based on results from the EXelon in PaRkinson's disease dementia Study (EXPRESS). EXPRESS is the first large-scale, prospective, randomized, double-blind, placebo-controlled, multicenter study with an Alzheimer's disease medication to demonstrate statistically significant improvement in the treatment of symptoms of Parkinson's disease dementia. Published in the New England Journal of Medicine in December 2004, EXPRESS included 541 patients and is the first and only prospective, large-scale trial to show benefits in patients with Parkinson's disease dementia. The outcomes were better in patients treated with Exelon compared to placebo (sugar pill) in both the primary and secondary variables. There was statistically significant improvement in overall functioning in patients treated with Exelon relative to deterioration seen in those treated with placebo, in cognition and certain aspects of behavior. Patients treated with Exelon also had less deterioration in their ability to perform activities of daily living than patients who received placebo. Patients enrolled in the study had mild to moderately severe dementia, which developed at least two years after they were diagnosed with Parkinson's disease. "The outcomes demonstrated in this trial by patients taking Exelon can translate into meaningful gains -- such as taking a more active role in everyday life, interacting with loved ones, and maintaining independence longer -- all of which can make a real difference for both patients and their families," said Jeffrey Cummings, MD, Professor of Neurology at the University of California, Los Angeles. "Exelon has consistently demonstrated efficacy in the treatment of Alzheimer's disease patients and can now also benefit individuals living with Parkinson's disease dementia." In March 2006, Exelon was granted European marketing authorization for the treatment of Parkinson's disease dementia in all 25 European member states, making it the only medication available to treat the condition in the European Union. Exelon has also been approved to treat Parkinson's disease dementia in 14 other countries around the world. New Nationwide Survey Underscores Impact of the Condition and Need for Effective Treatments A nationwide survey of 660 U.S. adults caring for a loved one with Parkinson's disease conducted by Harris Interactive(R) recently showed that the impact of Parkinson's disease is significantly affected by whether or not their loved one has dementia. Compared to caregivers of Parkinson's patients without dementia, caregivers for patients with Parkinson's disease dementia spend twice as many hours per day taking care of their loved one. In addition, they are significantly more likely to describe themselves as feeling frustrated, depressed, overwhelmed, emotionally drained, physically exhausted or unable to cope. Perhaps the most compelling measures of the toll taken by Parkinson's disease dementia are the facts that caregivers are nearly three times as likely to have hired full or part time professional help to provide care; and they are twice as likely to have sought help for themselves from a medical or mental healthcare provider. The survey also found that nearly nine in ten people caring for a loved one with Parkinson's disease dementia believe their family member's quality of life would improve and that it would be easier to care for their loved one if there were an effective treatment available for the condition. About Parkinson's Disease Dementia Parkinson's disease is a chronic and progressive disease of the nervous system. The four primary symptoms of Parkinson's include: rigidity of the limbs; tremor (trembling or shaking) of a limb, especially when the body is at rest; slow movement and postural instability, which is often perceived as unsteadiness or lack of balance. The primary symptoms of Parkinson's disease dementia include cognitive impairment and neuro-psychiatric symptoms (e.g., depression, hallucinations, anxiety and apathy). These symptoms impact the patient's quality of life, course of the disease and caregiver distress. As with Alzheimer's disease, Parkinson's disease dementia is associated with a cholinergic deficit, which results in decreased transmission of signals between nerves in the brain, especially those that rely on the neurotransmitter acetylcholine. This deficit contributes to the cognitive and behavioral problems observed in these patients. About the Survey Harris Interactive conducted the survey on behalf of Novartis Pharmaceuticals Corporation. The 15-minute survey was administered online from April 19 - May 24, 2006. Responses from 660 U.S. adults (age 22 and older) who are taking care of a friend or family member suffering from Parkinson's disease (PD) were analyzed. Respondents were recruited from three sources: Harris Interactive's online caregiver panel; a mass mailing conducted by the American Parkinson Disease Association (APDA); and a link on the National Parkinson Foundation (NPF) website. The results were then weighted using demographic variables including age by sex, household income, education, race, and geographic region and a variable called a propensity score that captures attitudinal and behavioral differences between those who are online versus those who are not, those who join online panels versus those who do not, and those who responded to this survey invitation versus those who did not. Harris Interactive's proprietary propensity weighting approach helps to minimize both demographic and attitudinal biases to ensure that the survey's results are projectable to the U.S. population of Parkinson's caregivers, including those with and without internet access. Safety Information About Exelon In the EXPRESS study Exelon was generally well tolerated. The most frequent side effects associated with Exelon were nausea and vomiting, which were mild to moderate in nature. More patients treated with Exelon reported increased tremor than did patients on placebo, but this rarely resulted in withdrawal from the study and the rating scale used to measure motor function in Parkinson's disease (UPDRS III) did not show a significant deterioration relative to baseline nor a statistically significant increase in tremor between Exelon and placebo. Exelon is also approved for the treatment of mild to moderate Alzheimer's disease. It has been administered to over 3 million patients worldwide and is cleared for marketing in over 70 countries. Exelon use is associated with significant stomach-related side effects, including nausea, vomiting, loss of appetite, and weight loss. If therapy is interrupted for longer than several days, treatment should be reinitiated with the lowest daily dose in order to avoid the possibility of severe vomiting and its potentially serious consequences. In clinical studies, stomach-related side effects occurred more frequently as doses were increased. The weight loss associated with Exelon occurred more commonly among women receiving high doses in clinical studies. Because these side effects can be serious, caregivers should be encouraged to monitor for these adverse events and inform the physician if they occur. People at risk for certain heart conditions or stomach ulcers should notify their doctor before starting Exelon therapy. In clinical studies, some patients also experienced fainting, weakness, and upset stomach. For more information, please see complete prescribing information at http://www.Exelon.com. SOURCE: Novartis Pharmaceuticals Corporation E-mail this page to a friend or colleague! To print, use this version