Results of a large-scale study published last week
in the International Journal of Geriatric Psychiatry show that Exelon®
Patch, the first skin patch in development for the treatment of Alzheimer's
disease, was well tolerated and provided benefits across a range of
symptoms 1.
Exelon Patch (rivastigmine transdermal patch) is designed to provide
smooth, continuous delivery of the drug through the skin. This 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.
During the 24-week IDEAL study of 1,195 patients with moderate Alzheimer's
disease 1, patients using once-daily Exelon Patch had improved memory and
thinking, and were better able to perform everyday activities than those on
placebo 1. In addition, the target dose of Exelon Patch 10 provided
equivalent efficacy to the highest doses of Exelon capsules with three
times fewer reports of nausea and vomiting 1. The patch showed a low level
of skin irritation and very good skin adhesion over 24 hours in a range of
everyday situations including bathing, and in hot weather 1.
In addition, more than 70 percent of caregivers in the IDEAL study
preferred the patch as a method of drug delivery for reasons including
aiding them to follow the treatment schedule, overall ease of use, and less
interference with daily life 2.
"In the IDEAL study, the Exelon Patch not only provided significantly
superior results compared to placebo, but also similar efficacy to the
highest dose of rivastigmine capsules, with dramatically improved
tolerability," said lead study investigator Professor Bengt Winblad of the
Karolinska Institute in Stockholm, Sweden. "These promising data indicate
that the Exelon Patch may provide an optimal way to deliver rivastigmine to
people with Alzheimer's disease."
Exelon (rivastigmine tartrate) is a dual cholinesterase inhibitor that is
already approved in oral form in many countries for the treatment of mild
to moderate Alzheimer's disease and dementia associated with Parkinson's
disease.
The IDEAL study results will support the regulatory submission of the
Exelon Patch to health authorities worldwide. If approved, the Exelon Patch
would be the first transdermal therapy for Alzheimer's disease, a
degenerative brain disorder that affects 24 million people worldwide 3.
About the IDEAL study
IDEAL (Investigation of Transdermal Exelon in Alzheimer's disease) was a
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 1. 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 US)
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
or Patch 20. Exelon Patch 10 provides equivalent exposure to the highest
doses of Exelon capsules (12 mg a day).
Both patch sizes showed superior efficacy to placebo 1. 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 1.
About Exelon capsules and Alzheimer's disease
Since 1997, Exelon 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, which increase the activity of
the neurotransmitter acetylcholine in the brain. Exelon is the only
cholinesterase inhibitor to be approved for both mild to moderate
Alzheimer's disease and Parkinson's disease dementia in Europe and the US.
Alzheimer's disease is a progressive disease that alters the brain, causing
impaired memory, thinking and behavior. Affecting 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 were estimated
at US$ 156 billion in 2003.
Disclaimer
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.
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
101,000 associates and operate in over 140 countries around the world. For
more information, please visit novartis.
References
1 Winblad B, Cummings J, et al. A 6-Month Double-blind, Randomized,
Placebo-Controlled Study of A Transdermal Patch in Alzheimer'd Disease -
Rivastigmine Patch versus Capsule. International Journal of Geriatric
Psychiatry. (In press)
2 Winblad B, Beusterien KM, et al. Caregivers prefer patches to
capsules: results from a 24-week placebo controlled study of rivastigmine
(IDEAL trial). Poster presented at the 10th International Congress of
Alzheimer's and Related Disorders (ICAD), Madrid, Spain, 19 July 2007.
3 World Health Organization. Neurological Disorders Affect Millions
Globally: WHO Report. Accessed online at:
who.int/mediacentre/news/releases/2007/pr04/en/index.html
View drug information on Exelon.
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