Healthcare Industry News: Transdermal
News Release - July 19, 2006
Exelon(R) Patch, the first transdermal therapy for Alzheimer's disease, may provide a promising new approach to treatmentIDEAL study shows potential of once-daily Exelon Patch for improving memory and maintaining everyday activities of Alzheimer's patients, with good tolerability
Over 70% of caregivers preferred patches to capsules due to better compliance and less interference with daily lives
Alzheimer's disease, the most common form of dementia, affects an estimated 15 million people worldwide
EAST HANOVER, N.J., July 19 (HSMN NewsFeed) -- An international study of the first Transdermal patch for patients with Alzheimer's -- a degenerative brain disease estimated to affect more than 15 million people worldwide -- has shown that it may provide a promising new treatment approach.
The six-month IDEAL trial of 1,195 patients with moderate Alzheimer's disease showed that the ExelonŽ Patch provided benefits across a range of symptoms and the target dose was well tolerated. Results were presented today at the 10th International Conference on Alzheimer's Disease and Related Disorders (ICAD), presented by the Alzheimer's Association in Madrid, Spain.
Patients receiving Exelon Patch (rivastigmine Transdermal patch) had significant improvements in memory and were better able to maintain everyday activities than those receiving placebo. They could also complete a concentration task faster compared to those taking placebo, and physicians considered Exelon Patch patients to have done better overall.
In addition, over 70% of caregivers in the IDEAL study preferred the patch to capsules as a method of drug delivery for reasons including helping them follow the treatment schedule, citing overall ease of use and less interference with daily life, according to a questionnaire in the study.
"The patch may prove to be the best way to deliver rivastigmine to treat Alzheimer's disease by allowing patients to achieve good efficacy with improved tolerability," said Jeffrey Cummings, MD, Professor of Neurology at the University of California, Los Angeles. "The target rivastigmine patch dose provided similar efficacy to that achieved at the highest doses of the capsule with tolerability similar to placebo."
Transdermal patches are designed to provide controlled, continuous delivery of drug through the skin. This maintains steady drug levels in the bloodstream, which may improve tolerability and consequently allow access to higher doses. In addition, patches may help caregivers to monitor treatment compliance because they provide visual reassurance that the medication has been taken.
"Although Alzheimer's disease treatments have been available in oral forms for some time, we believe a patch may offer unique advantages for patients with this condition," said James Shannon, MD, Global Head of Development at Novartis Pharma AG. "If approved, the Exelon Patch could potentially improve therapy compliance and help patients and their caregivers in reaching a better quality of life."
Exelon is a cholinesterase inhibitor already approved in many countries for the treatment of mild to moderate Alzheimer's disease and Parkinson's disease dementia. The IDEAL results will support the regulatory submission of the Exelon Patch to the U.S. Food and Drug Administration, planned by the end of 2006.
About the IDEAL study
IDEAL (Investigation of Transdermal Exelon in Alzheimer's disease) was a 24-week, multi-center, randomized, double-blind, placebo- and active-controlled trial to compare the efficacy, safety and tolerability of the once-daily Exelon Patch with conventional twice-daily Exelon capsules in patients with moderate Alzheimer's disease. The primary outcome measures were the Alzheimer's Disease Assessment Scale -- cognitive subscale (ADAS-cog) and Alzheimer's Disease Cooperative Study -- Clinical Global Impression of Change (ADSC-CGIC).
IDEAL was conducted in 21 countries and involved 100 centers (23 in the U.S.) and 1,195 patients aged 50-85 years old with a score of 10-20 in the Mini-Mental State Examination (MMSE), the most widely-used test for assessing memory problems or dementia. Patients received Exelon either in capsules (up to 6 mg twice-daily) or patches in two sizes, namely Patch 10 (providing 9.5 mg over 24 hours) or Patch 20 (17.4 mg/24 h).
Both patch sizes showed superior efficacy to placebo. The target dose of Patch 10 showed similar efficacy to the highest doses of Exelon capsules with three times fewer reports of nausea (7.2 percent vs. 23.1 percent) and vomiting (6.2 percent vs. 17.0 percent), which are well-known side effects of cholinesterase inhibitors. Patch 20 showed numerically, but not statistically, improved cognitive scores versus capsules and similar tolerability to capsules.
Local skin tolerability was good. The percentage of patients who reported moderate or severe redness of the skin at any point of the study was only 7.6 percent and 6.2 percent of patients receiving Patch 10 and 20, respectively. The patch also demonstrated very good skin adhesion over 24 hours in a range of everyday situations such as bathing and in hot weather.
Since 1997, Exelon (rivastigmine tartrate) has been widely used to treat mild to moderate Alzheimer's disease in more than 70 countries. Exelon belongs to a class of drugs known as cholinesterase inhibitors (ChEIs), which increase the activity of the neurotransmitter acetylcholine in the brain. Exelon is the only cholinesterase inhibitor to be also approved to treat both mild to moderate Alzheimer's disease and Parkinson's disease dementia in Europe and U.S.
Important safety information
In controlled clinical trials with EXELON capsules, the most common adverse events were nausea, vomiting, anorexia, dyspepsia, asthenia and tremor. EXELON has been associated with significant gastrointestinal adverse reactions, including nausea and vomiting, anorexia, 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 is potentially serious sequelae. Weight loss associated with EXELON occurred more commonly among women receiving high doses in clinical trials. Due to increased cholinergic activity, cholinesterase inhibitors may be expected to increase gastric acid secretion and/or have vagotonic effects on heart rate. Therefore, EXELON should be used with caution in patients with peptic ulcers, gastrointestinal bleeding, "sick sinus syndrome" or other supraventricular cardiac conduction conditions, and in those who use NSAIDs. For more information, please see complete prescribing information at http://www.Exelon.com.
About Alzheimer's disease
Alzheimer's disease is a progressive, degenerative disease that alters the brain, causing impaired memory, thinking and behavior. Affecting approximately 15 million people worldwide and two to six percent of those over 65 years of age, it is the most common form of dementia and the third leading cause of death in this age group behind cardiovascular disease and cancer. The worldwide direct costs for dementia in 2003 are estimated at $156 billion.
This release contains certain forward-looking statements relating to the Novartis Group's business, which can be identified by the use of forward-looking terminology such as "may", "will", "could", "if approved", "planned by", or similar expressions, or by express or implied discussions regarding potential future regulatory submissions for Exelon or the Exelon Patch, or regarding potential future revenue from Exelon or the Exelon Patch. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results with Exelon or the Exelon Patch to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that any regulatory submissions regarding the Exelon Patch will be made as planned or, if made, will be successful. Neither can there be any guarantee regarding potential future revenue from Exelon or the Exelon Patch. In particular, management's expectations regarding commercialization of Exelon or the Exelon Patch could be affected by, among other things, additional analysis of Exelon clinical data; new clinical data; unexpected clinical trial results; unexpected regulatory actions or delays in government regulation generally; the ability of Novartis to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry, and general public pricing pressures; as well as factors discussed in Novartis AG's Form 20-F filed with the U.S. Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
Novartis Pharmaceuticals Corporation develops, manufactures, markets and sells leading innovative prescription drugs used to treat a number of diseases and conditions, including those in the cardiovascular, metabolic, cancer, organ transplantation, central nervous system, dermatological, gastrointestinal and respiratory areas. The company's mission is to improve people's lives by pioneering novel healthcare solutions.
Novartis has been a leader in the neuroscience area for more than 50 years, having pioneered early breakthrough treatments for Alzheimer's disease, Parkinson's disease, attention deficit/hyperactivity disorder, epilepsy, schizophrenia and migraine. Novartis continues to be active in the research and development of new compounds, and is committed to addressing unmet medical needs and to supporting patients and their families affected by these disorders.
Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG (NYSE: NVS ) -- a world leader in offering medicines to protect health, treat disease and improve well-being. Our goal is to discover, develop and successfully market innovative products to treat patients, ease suffering and enhance the quality of life. Novartis is the only company with leadership positions in both patented and generic pharmaceuticals. We are strengthening our medicine-based portfolio, which is focused on strategic growth platforms in innovation-driven pharmaceuticals, high-quality and low-cost generics and leading self-medication OTC brands. In 2005, the Group's businesses achieved net sales of USD 32.2 billion and net income of USD 6.1 billion. Approximately USD 4.8 billion was invested in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 91,000 people and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com.
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