What is Comtess?
Comtess is a drug containing the active substance entacapone, available in 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, slowness of movement and muscle stiffness. Comtess 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. Comtess 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 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 taking Comtess 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. Comtess 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 Comtess 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 ingredient in Comtess, 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 neutrasmator, 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 Comtess?
Comtess was examined in a total of 376 patients suffering from Parkinson's disease, in two studies lasting six months, which analyzed the effects of the administration of Comtess or placebo (a dummy treatment) as an adjunctive therapy compared 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 Comtess shown during the studies?
In both studies, Comtess was more effective than placebo. In the first study, the addition of Comtess to levodopa therapy extended the time to "on" by 1 hour and 18 minutes compared to placebo, while 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 Comtess?
The most common side effects with Comtess (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 Comtess, see the Package Leaflet. Comtess should not be used in people who may be hypersensitive (allergic) to entacapone or any of the other ingredients. Comtess should not be given to patients:
• suffering from 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).
Comtess 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 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 the standard preparations based on levodopa / benserazide or levodopa / carbidopa for the treatment of patients with Parkinson's disease with fluctuations daily "end of dose" motor list that cannot be stabilized with the aforementioned combinations and therefore recommended the release of the product marketing authorization.
More information on Comtess:
On 16 September 1998, the European Commission granted a marketing authorization for Comtess, valid throughout the European Union, to the Orion Corporation. The marketing authorization was renewed on 16 September 2003 and 16 September 2008.
The full EPAR for Comtess can be found here.
Last update of this summary: 08-2008.
