FDA Approves Entacapone For Treatment Of Parkinson's Disease
WESTPORT, Oct 21 (Reuters Health) - On Wednesday, the US Food and Drug Administration granted approval to Novartis Pharmaceuticals Corp. of East Hanover, New Jersey, to market entacapone (Comtan) as adjunctive treatment for patients with Parkinson's disease.
According to the company, entacapone inhibits catechol-O-methyltransferase (COMT), an enzyme involved in the metabolism of levodopa. With the enzyme's activity blocked, more levodopa reaches the brain, boosting its action, Dr. C. Warren Olanow of Mt. Sinai Medical Center in New York explained in a statement.
Dr. Olanow was an investigator in one of the clinical trials of entacapone, which collectively involved approximately 30,000 patients with Parkinson's disease who demonstrated "wearing off" of levodopa.
The addition of entacapone to levodopa therapy increased "on" time without any evidence of adverse effects, he told Reuters Health. The use of another COMT inhibitor, tocapone, is associated with significant hepatotoxicity, he said, but none has been noted in patients on entacapone.
With more levodopa available in the brain, the dosage of levodopa may need to be titrated down once entacapone is added, Dr. Olanow noted.
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