Comtess - entacapone

What is Comtess?

Comtess is a medicine containing the active substance entacapone, available as orange-brown tablets (200 mg).

What is Comtess used for?

Comtess is indicated for the treatment of patients with Parkinson's disease. Parkinson's disease is a progressive mental disorder that causes tremor, slow movement, and muscle stiffness. Comtess is used in addition to levodopa (a combination of levodopa and benserazide or a combination of levodopa and carbidopa) if the patient experiences "fluctuations" towards the end of the time interval between two doses. Fluctuations occur when the effects of the drug diminish and the symptoms re-emerge. The fluctuations are related to a reduction in the effects of levodopa, whereby the patient undergoes sudden changes between the "on" state, in which he is able to move, and the "off" state , where you have difficulty moving. Comtess is given when these fluctuations cannot be stabilized with the standard preparation alone which contains levodopa.The medicine can only be obtained with a prescription.

How is Comtess used?

Comtess should only be used in combination with levodopa and benserazide or with levodopa e
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 Comtess as an add-on to existing treatment, it may be necessary to reduce the daily dose of levodopa by extending the dose interval or by using less levodopa in doses. Comtess can only be used with traditional preparations of levodopa The medicine should not be given together with 'modified release' preparations (ie when levodopa is released slowly over a few hours).

How does Comtess work?

In patients with Parkinson's disease, the brain cells that produce the neutransmitter dopamine begin to die, resulting in a decrease in the concentration of this substance in the brain. Patients therefore lose the ability to reliably control their movements. The active substance in Comtess, entacapone, helps restore dopamine levels in the areas of the brain responsible for controlling movement and coordination. It only works when given in combination with levodopa, a copy of the neutransmitter dopamine, 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 stays active longer, helping to improve symptoms of Parkinson's disease, such as stiffness and slowness of movement.

How has Comtess been studied?

Comtess was studied in a total of 376 patients with Parkinson's disease in two six-month studies investigating the effects of administering Comtess or placebo (a dummy treatment) as add-on 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 levodopa controls the symptoms of Parkinson's disease) after the first dose of levodopa. morning in the first studio and over a day in the second studio.

What benefit has Comtess shown during the studies?

In both studies, Comtess was more effective than placebo. In the first study, adding Comtess to levodopa therapy extended the "on" time by 1 hour and 18 minutes compared to placebo, while in the second study, the "on" interval increased by 35 minutes compared to placebo. to that recorded with the intake of placebo.

What are the risks associated with Comtess?

The most common side effects with Comtess (seen in 1 to 10 patients in 100) are dyskinesia (involuntary movements), nausea and harmless urine discoloration. For the full list of side effects reported with Comtess, see the package leaflet. Comtess must not be used in people who may be hypersensitive (allergic) to entacapone or any of the other ingredients. Comtess must not be used in patients:

• suffering from liver disease;
• have pheochromocytoma (a tumor of the adrenal gland);
• with a history of neuroleptic malignant syndrome (a serious nervous system disorder usually caused by antipsychotic drugs) or rhabdomyolysis (breakdown of muscle fibers).

Comtess must not be used at the same time as other medicines 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 Comtess been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Comtess's benefits are greater than its risks in addition to standard levodopa / benserazide or levodopa / carbidopa preparations for the treatment of fluctuating patients with Parkinson's disease. daily "end-of-dose" motor movements and which cannot be stabilized with the aforementioned combinations and therefore recommended the release of the "marketing authorization" of the product.

Other information about Comtess:

On September 16, 1998, the European Commission granted Orion Corporation a "marketing authorization" for Comtess, valid throughout the European Union. The "marketing authorization" was renewed on September 16, 2003 and on September 16. 2008.
For the full version of Comtess EPAR click here.

Last update of this summary: 08-2008.

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