What is Comtan?
Comtan is a drug containing the active substance entacapone, available in orange-brown tablets (200 mg).
What is Comtan used for?
Comtan is indicated for the treatment of patients with Parkinson's disease. Parkinson's disease is a progressive mental disorder that causes tremor, slowness of movement and muscle stiffness. Comtan is used in addition to levodopa (a combination of levodopa and benserazide or a combination of levodopa and carbidopa) in case the patient accuses "fluctuations" towards the end of the time interval between the administration of two doses. Fluctuations occur when the effects of the drug decrease and symptoms re-emerge. The fluctuations are linked to a reduction in the effects of levodopa, whereby the patient is subjected to sudden changes between the "on" state, in which he is able to move, and the "off" state, in which he has difficulty in movement. Comtan is administered when these fluctuations cannot be stabilized with the standard preparation containing levodopa alone. The medicine can only be obtained with a prescription.
How is Comtan used?
Comtan should only be used in combination with levodopa and benserazide or with levodopa and carbidopa. The recommended dose is one tablet taken with each dose of the associated drug, up to a maximum of 10 tablets per day. The medicine can be taken with or without food. When patients start taking Comtan as an adjunct to ongoing treatment, it may be necessary to reduce the daily dose of levodopa by prolonging the interval between doses or by using a lower amount of levodopa in the doses. Comtan can only be used with traditional levodopa preparations. The medicine should not be administered together with "modified release" preparations (ie when levodopa is released slowly over a few hours).
How does Comtan work?
In patients with Parkinson's disease, the brain cells that produce the dopamine neutralizer begin to die, resulting in a decrease in the concentration of this substance in the brain. Patients therefore lose the ability to control their movements reliably. The active substance in Comtan, entacapone, helps restore dopamine levels in the areas of the brain responsible for controlling movement and coordination. It acts only when administered in combination with levodopa, a copy of the dopamine neutrasmitrator, which can be taken by mouth. Entacapone blocks an enzyme involved in the absorption of levodopa in the body called catechol-O-methyl transferase (COMT). As a result, levodopa remains active longer, helping to improve the symptoms of Parkinson's disease, such as stiffness and slowness in movement.
What studies have been carried out on Comtan?
Comtan has been studied in a total of 376 Parkinson's disease patients, in two six-month studies, which analyzed the effects of Comtan or placebo (a dummy treatment) as an adjunctive therapy to the preparation of levodopa and carbidopa or levodopa and benserazide already used by the patient. The main measure of effectiveness was the time spent in the "on" state (ie the time when levodopa controls the symptoms of Parkinson's disease) after the first dose of levodopa in the morning in the first study and in one day in the second study.
What benefit has Comtan shown during the studies?
In both studies Comtan was more effective than placebo. In the first study, the addition of Comtan to levodopa therapy extended the time to "on" by 1 hour and 18 minutes compared to placebo, whereas in the second study the interval on "on" increased by 35 minutes compared to placebo. to that recorded with placebo.
What are the risks associated with Comtan?
The most common side effects with Comtan (seen in between 1 and 10 patients in 100) are dyskinesia (involuntary movements), nausea and harmless urine staining. For the full list of all side effects reported with Comtan, see the Package Leaflet.
Comtan should not be used in people who may be hypersensitive (allergic) to entacapone or any of the other ingredients. Comtan should not be used in patients:
• liver disease,
• suffering from pheochromocytoma (a tumor of the adrenal gland);
• with a history of neuroleptic malignant syndrome (a serious nervous system disorder normally caused by antipsychotic drugs) or rhabdomyolysis (rupture of muscle fibers);
Comtan should not be used simultaneously with other drugs belonging to the group of "monoamine oxidase inhibitors" (a type of antidepressant). For further details, please refer to the Summary of Product Characteristics, included in the EPAR.
Why has Comtan been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Comtan's benefits are greater than its risks in addition to the standard preparations of levodopa / benserazide or levodopa / carbidopa for the treatment of patients with Parkinson's disease who have fluctuations "end-of-dose" day-to-day motor skills that cannot be stabilized with the above combinations, and has therefore recommended that the product be granted marketing authorization.
More information on Comtan
On 22 September 1998, the European Commission granted a marketing authorization valid for Comtan, valid throughout the European Union, to Novartis Europharm. The marketing authorization was renewed on 22 September 2003 and 22 September 2008.
The full EPAR for Comtan can be found here.
Last update of this summary: 08-2008
