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Forwarded Message:
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Forwarded Message:
Date: Friday, January 30, 1998 5:33:42 PM
From: AOL News
Subj: FDA Clears Parkinson's Drug TASMAR(R) Tolcapone) for...
FDA Clears Parkinson's Drug TASMAR(R) Tolcapone) for U.S. Marketing; First of
a New Class of Drugs Called COMT Inhibitors
NUTLEY, N.J., Jan. 30 /PRNewswire/ -- Hoffmann-La Roche announced today that
it received clearance from the U.S. Food and Drug Administration to market
TASMAR(R) (tolcapone), the first of a new class of Parkinson's disease drugs
called COMT inhibitors. TASMAR significantly improves a patient's ability to
function and perform basic daily activities when taken in combination with the
current standard of therapy, levodopa/carbidopa. Clinical studies found that
advanced Parkinson's disease patients gained a daily average of 1.7 - 2.9
hours of "on" time, periods of relatively good functioning, with the combined
therapy.
TASMAR is indicated for use in conjunction with levodopa/carbidopa, in both
"non-fluctuating" and "fluctuating" Parkinson's disease patients. TASMAR was
evaluated in patients whose Parkinson's disease was characterized by
deterioration in their response to levodopa at the end of a dosing interval
("fluctuating patients" with wearing-off phenomena). Additionally it was
evaluated in patients whose response to levodopa was relatively stable ("non-
fluctuators").
A progressive neurological disorder, Parkinson's disease affects one and one-
half million Americans. Symptoms include uncontrollable tremors or shaking,
slowness of movements, stiffness, poor balance and a shuffling walk. There is
no cure for Parkinson's disease; current therapies focus on symptom control.
"TASMAR is an important new option for the treatment of Parkinson's disease.
When used in conjunction with levodopa, patients experience rapid and
significant improvement in many of their symptoms," said William Koller, M.D.,
Chairman, Department of Neurology, University of Kansas Medical Center.
"Patients enjoy fewer tremors, improved mobility and overall improvement in
conducting daily activities."
Clinical Trials Demonstrate Improvement
In worldwide clinical trials with more than 1,500 patients, TASMAR was shown
to enhance and extend the pharmacologic actions and clinical benefits of
levodopa/carbidopa.
Non-fluctuating patients taking TASMAR experienced statistically significant
improvements in activities of daily living as assessed by the Unified
Parkinson's Disease Rating Scale (UPDRS), which measures such activities as
speech, handwriting, walking and dressing. These patients also experienced
improved motor function.
In clinical studies, fluctuating patients gained a daily average of 1.7 - 2.9
hours of "on-time". In addition, these patients experienced a significant
improvement in their symptoms, overall, as measured by the investigator's
global assessment of change.
COMT Inhibition
While the precise mechanism-of-action is unknown, it is believed that COMT
inhibitors work to enhance the effectiveness of levodopa by blocking one of
the main enzymes (catechol-O-methyltransferase) responsible for breaking down
levodopa in the bloodstream, before it reaches the brain.
By inhibiting the action of the COMT enzyme, TASMAR, a COMT inhibitor,
provides smoother and more sustained levels of levodopa to the brain which it
is believed translates into more consistent and effective symptom relief for
people with Parkinson's disease.
Extending the benefit of levodopa is important. Over time, Parkinson's
disease progresses and larger and/or more frequent doses of levodopa are
needed to relieve Parkinson's symptoms. Patients experience levodopa-induced
side effects, like uncontrolled movements (dyskinesias) and begin to fluctuate
between periods of relatively good functioning ("on-time") and periods of
relatively poor functioning ("off-time"). Clinical studies demonstrated that
by extending the effectiveness of each dose of levodopa, TASMAR helped to
"smooth out" these on-off periods -- thus increasing patients' functioning
throughout the day.
"This is an exciting time for new research and treatment developments to
manage Parkinson's disease. Although we're still looking for a cure, COMT
inhibitors represent an entirely new class of therapy that will help the many
Parkinson's disease patients to attain better symptom control," said Emilio
Alonso-Mendoza, executive director, National Parkinson Foundation.
In clinical trials, the most common side effects were dyskinesias (involuntary
movements), nausea, sleep disorders, dystonia, anorexia, diarrhea, somnolence,
excessive dreaming, muscle cramps, orthostatic complaints/syncope, dizziness,
headache, hallucination and confusion. TASMAR may potentiate the dopaminergic
side effects of levodopa and may require decreasing the dose of levodopa;
however some may persist despite levodopa dose adjustment. Diarrhea was the
side effect which most commonly led to discontinuation. Liver transaminases
should be monitored when initiating TASMAR and as recommended for the first 6
months.
To be marketed by Hoffmann-La Roche, TASMAR will be supplied in 100 mg. and
200 mg. tablets. It will be available in pharmacies nationwide beginning late
February.
Hoffmann-La Roche Inc. is a leading research-intensive pharmaceutical company
that discovers, develops, manufactures and markets numerous important
prescription drugs that improve, prolong and save the lives of patients with
serious illnesses. Hoffmann-La Roche has a strong history in the Parkinson's
disease arena as the developer of LARODOPA(TM) (levodopa), (the first levodopa
product), and MADOPAR(TM) (levodopa/benserazide), the leading Parkinson's
medication used outside the U.S. Among the company's areas of therapeutic
interest are central nervous system disorders, virology, including HIV and
AIDS, infectious diseases, cardiology, oncology, transplantation, dermatology
and obesity.
The company provides a wide range of medications in the United States through
its marketing and sales subsidiary, Roche Laboratories Inc. Headquartered in
Nutley, N.J., both companies are members of the Basel, Switzerland-based Roche
Group, a global leader in health care with principal businesses in
pharmaceuticals, diagnostics, vitamins, and fragrances and flavors.
NOTE: Full prescribing information available upon request.
.
