Exelon Patch, the First and Only Skin Patch for the Treatment of Alzheimer's Disease, Receives First Worldwide Approval in US
Once-daily skin patch offers novel approach to treating mild to moderate Alzheimer's disease, providing smooth and continuous elivery of drug over 24 hours
EAST HANOVER, N.J., July 09, 2007 /PRNewswire-FirstCall/ -- Exelon Patch (rivastigmine transdermal system) has received its first worldwide approval in the United States as an innovative way to deliver an effective medicine for mild to moderate Alzheimer's disease patients through a skin patch instead of an oral capsule.
This new therapy is the first and only transdermal treatment for this degenerative condition affecting millions of people in the US. Exelon Patch offers effective treatment based on placebo-controlled clinical trial results showing significant benefits to patients in terms of their memory and overall functioning.
Exelon Patch maintains steady drug levels in the bloodstream, improving tolerability and allowing a higher proportion of patients to receive therapeutic doses compared to the capsule form of the medication. It is applied to the back, chest or upper arm, and provides smooth and continuous delivery of medication through the skin over 24 hours.
Gastrointestinal side effects are commonly seen with this class of drugs called cholinesterase inhibitors. The recommended dose of Exelon Patch greatly reduces these side effects, with three times fewer reports of nausea and vomiting than with the capsule form of the drug.
"Exelon Patch represents a significant advance in the treatment of this debilitating disease," said George Grossberg, MD, Director of Geriatric Psychiatry, St. Louis University School of Medicine, St. Louis, Missouri. "The unique delivery system helps both the patient and the caregiver by providing an easy way to manage their therapy. The patch provides a visual reassurance for the caregiver that the patient is receiving their medication and helps the patient stay engaged in their daily lives."
Exelon Patch is expected to be available in US pharmacies soon. The medication was submitted for review in the European Union in late 2006.
The patch was designed with compliance in mind and was preferred to capsules by 70% of caregivers as a method of drug delivery according to clinical study data, because it helped them follow the treatment schedule, interfered less with their daily life and was easier to use overall than the oral medication.
The approval of Exelon Patch is based on results from the international IDEAL (Investigation of transDermal Exelon in ALzheimer's disease) clinical trial, involving nearly 1,200 patients with mild to moderate Alzheimer's disease. Exelon Patch showed similar efficacy to the highest doses of Exelon capsules and the recommended dose (9.5 mg/24 hours) was generally well tolerated by patients.
"Innovation isn't just about developing new compounds, but also about meeting therapeutic needs by taking existing knowledge and applying it in new ways," said James Shannon, MD, Global Head of Development at Novartis Pharma AG. "Exelon Patch addresses an important medical need by delivering a proven drug in an entirely new form that meets the needs of patients and their caregivers."
Alzheimer's disease is a progressive, degenerative disease that alters the brain, causing impaired memory, thinking and behavior. Approximately 18 million people worldwide have Alzheimer's disease. In the US, more than five million people suffer from Alzheimer's disease and almost 10 million people provide care for someone living with dementia, most of which is related to Alzheimer's disease. By 2030, the number of people in the US who are age 65 and over with Alzheimer's disease is estimated to reach 7.7 million, 50% more than current levels.
The U.S. Food and Drug Administration also approved the use of Exelon Patch in treating patients with mild to moderate Parkinson's disease dementia. Parkinson's disease is a chronic and progressive neurological condition that affects approximately 1.5 million people in the US. Parkinson's disease dementia is a distinct and common disorder, one characterized by impairments in executive function, memory retrieval, and attention, in patients with an established diagnosis of Parkinson's disease for at least two years. Two out of five people with Parkinson's disease are estimated to have Parkinson's disease dementia.
Important Safety Information
Exelon Patch (rivastigmine transdermal system) is indicated for the treatment of mild to moderate dementia of the Alzheimer's type and mild to moderate dementia associated with Parkinson's disease. Exelon Patch is contraindicated in patients with known hypersensitivity to rivastigmine, other carbamate derivatives or other components of the formulation.
At higher than recommended doses, Exelon Patch use is associated with nausea, vomiting, diarrhea, anorexia/decreased appetite and weight loss. For this reason, patients administered the Exelon Patch should always be started at a dose of 4.6 mg/24 hours and titrated to the maintenance dose of 9.5 mg/24hours.
In a clinical trial, the most commonly observed adverse events occurring at a frequency of at least 5% and greater than placebo with administration of 9.5 mg/24 hours were nausea, vomiting and diarrhea (7%, 6%, 8% for Exelon Patch 9.5 mg/24 hours versus 5%, 3%, 6% for placebo, respectively). Weight should be monitored during Exelon Patch therapy. In clinical trials for dementia associated with Parkinson's disease, Exelon capsules have been observed to increase the incidence or intensity of tremor.
As with other cholinomimetics, caution is recommended in patients with sick sinus syndrome, conduction defects, gastroduodenal ulcerative conditions (including those predisposed by concomitant medications), asthma or chronic obstructive pulmonary disease, urinary obstruction, and seizures. For full prescribing information, go to www.ExelonPatch.com.
The foregoing press release contains forward-looking statements that can be identified by forward-looking terminology, such as "expected to be", or implied statements regarding potential future revenues from the Exelon Patch. Such statements involve known and unknown risks, uncertainties and other factors that may cause the actual results to be materially different from any future results, performance, or achievements expressed or implied by such statements. There can be no guarantee that Exelon Patch will reach any particular sales levels. In particular, management's expectation regarding the commercial success of Exelon Patch could be affected by among other things, uncertainties relating to product development, regulatory actions or delays or government regulation generally, the ability to obtain or maintain patent or other proprietary intellectual property protection and competition in general, as well as factors discussed in the Form 20F filed with the 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 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 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, many of which continue to be regarded as "gold standards" to this day. Novartis Neuroscience continues to be at the forefront of research and development of new compounds, is committed to addressing unmet medical needs and to supporting patients and families affected by these disorders.
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.
Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG , a world leader in offering medicines to protect health, cure 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. We are strengthening our medicine-based portfolio, which is focused on strategic growth platforms in innovation-driven pharmaceuticals, high-quality and low-cost generics, human vaccines and leading self-medication OTC brands. Novartis is the only company with leadership positions in these areas. In 2006, the Group's businesses achieved net sales of USD 37.0 billion and net income of USD 7.2 billion. Approximately USD 5.4 billion was invested in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 100,000 associates and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com.
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Posted: July 2007