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| |  FDA Clears Parkinson's Drug Tasmar NUTLEY, NJ -- January 30, 1998 -- The United States Food and Drug Administration has granted marketing clearance to Hoffmann-La Roche’s 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 relatively good functioning, with the combined therapy. The drug 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 characterised 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 of the department of neurology, University of Kansas Medical Center. "Patients enjoy fewer tremors, improved mobility and overall improvement in conducting daily activities." 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. 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. 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 six months. Tasmar will be supplied in 100 mg. and 200 mg. tablets. It will be available in pharmacies nationwide beginning late February 1998.
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