Here's info te TASMAR (Tolcapone) which was requested
>Date: Mon, 02 Feb 1998 12:12:09 -0500 (EST)
>From: "LIST Helen K. Mason" <[log in to unmask]>
>Subject: TASMAR
>Sender: Parkinson's Information Exchange <[log in to unmask]>
>To: Multiple recipients of list PARKINSN <[log in to unmask]>
>Reply-to: Parkinson's Information Exchange <[log in to unmask]>
>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.
>
>.
>
