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Alzheimer's, Dementia & Mental Health
Exelon Patch is First Approved by FDA to Treat
Alzheimer’s Disease
Patch also approved to treat Parkinson's disease
dementia
July 9, 2007 – Exelon Patch (rivastigmine) has
received the first worldwide approval in the United States by the Food
and Drug Administration of 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, according to a news release by
the drug company Novartis. The FDA also approved it to treat Parkinson’s
disease dementia, which strikes two out of five patients with
Parkinson’s.
This patch uses the same drug, rivastigmine, now available in
capsule. The patch, however, provides a regular and continuous dose
throughout the day, according to Novartis Pharmaceuticals Corp. Since
the drug enters the bloodstream directly, the patch reportedly
eliminates some of the gastrointestinal side effects associated with the
drug when swallowed.
Rivastigmine does not, however, cure the
disease, which strikes millions of American’s each year. Parkinson’s,
too, primarily strikes older people.
“Exelon Patch offers effective treatment based on
placebo-controlled clinical trial results showing significant benefits
to patients in terms of their memory and ability to perform everyday
tasks as well as helping their overall functioning,” the release states.
Novartis says Exelon Patch maintains steady drug
levels in the bloodstream, improving tolerability and allowing a higher
proportion of patients to receive therapeutic doses of medication, with
potential improvements in efficacy. 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 target
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,
at St. Louis University in St. Louis, Missouri.
"The unique delivery system helps both the patient
and the caregiver by providing a much easier 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 the activities of daily living."
Exelon Patch is expected to be available in U.S.
pharmacies soon, Novartis says.
Novartis Pharmaceuticals will distribute the patch,
which is manufactured by LTS Lohmann Therapie-Systeme AG, a German firm.
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 more than 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 capsules1 and the target dose
(9.5 mg/24 hours) was 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 U.S., 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 senior citizens in the U.S. who are age
65 and over with Alzheimer's disease is estimated to reach 7.7 million,
more than 50% more than current levels.
Parkinson’s Disease Dementia
The FDA 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 U.S.
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. Two of five people with Parkinson's
disease are estimated to have Parkinson's disease dementia.
The FDA has not yet made a publi release of the
approval.
About Novartis
Novartis AG (NYSE: NVS) is 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, visit
http://www.novartis.com.
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