Comtan
Company: Novartis
Approval Status: October 19, 1999
Treatment for: For Parkinson's patients being treated with levodopa therapy who experience end-of-dose "wearing off
Areas: Neurology
| General Information | Clinical Results | Side Effects | Mechanism of Action | Additional Information |
General Information
This new treatment in the management of idiopathic
Parkinson's Disease helps prolong the effects of the
levodopa/carbidopa preparations, such as improved motor performance
and increased amounts of "on" time (periods of good
function and mobility in which a patient is able to perform common
daily activities such as walking, speaking, and writing).
Comtan belongs to a class of therapeutic treatments called COMT
inhibitors which block the COMT enzyme. When taken with the
prescribed levodopa/carbidopa treatment, the inhibitor reduces the
breakdown of levodopa before it reaches the brain. As a result, the
effects of each levodopa dose are extended and enhanced.
Clinical Results
The effects of Comtan were tested on nearly 700 patients in worldwide, multi-center trials. Compared to a placebo, patients with Parkinson's who took Comtan demonstrated improved motor performance and had significantly increased amounts of "on" time each day. Several important Phase III studies indicated that the benefits were salient for patients who showed deteriorating response to levodopa/carbidopa, particularly in important activities of daily living such as speaking, handwriting, walking and dressing.
Side Effects
Comtan is generally well-tolerated and doesn't require any specific safety monitoring. The most commonly reported side-effects were dyskinesia, nausea, diarrhea, abdominal pain and urine discoloration. A very small percentage of participants in the trials also experienced hallucinations. Dopaminergic side effects like dyskinesia often improved after adjustment of the levodopa dosage.
Mechanism of Action
Entacapone inhibits COMT and alters the plasma pharmokinetics of levodopa. When entacapone is given in conjunction with levodopa and an aromatic amino acid decarboxylase inhibitor, such as carbidopa, plasma levels of levodopa are greater and more sustained than after administration of levodopa and an aromatic amino acid decarboxylase inhibitor alone. It is believed that at a given frequency of levodopa administration, these more sustained plasma levels of levodopa result in more constant dopaminergic stimulation in the brain, leading to greater effects on the signs and symptoms of Parkinson's disease. The higher levodopa levels also lead to increased levodopa adverse effects, sometimes requiring a decrease in the dose of levodopa. (FDA Label)
Additional Information
For more information about Comtan, call 1-888-669-6682.
Visit the Novartis web site:
www.us.novartis.com
The FDA drug information shown here is licensed from Thomson CenterWatch. The information provided here is for general educational purposes only and does not constitute medical or pharmaceutical advice which should be sought from qualified medical and pharmaceutical advisers.
