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FDA OKs New Drug for Parkinson's
Azilect blocks dopamine breakdown
- May 18 2006
Parkinson's patients on Wednesday gained a newly approved drug to help block the breakdown of a chemical that contributes to problems with movement and coordination that mark the progressive disease.
The Food and Drug Administration said it approved Azilect, also called rasagiline, for use as an initial single-drug therapy for early Parkinson's disease, and as an addition to levodopa in more advanced patients. Levodopa is a standard treatment for Parkinson's.
"Parkinson's is a relentless disease with limited treatment options, and each new therapy is an important addition to the physicians' treatment options," said Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research.
Azilect is intended to help block the breakdown of dopamine, an important chemical for the cellular signaling that controls muscle movement.
Azilect comes from a class of drugs that can cause dangerous interactions, including sudden and severe rises in blood pressure that may lead to stroke and death, when patients consume food or drinks that contain a substance called tyramine. That substance is found in draft beer, red wine, fava beans, salamis, aged cheeses, soy sauce and other products.
Azilect, made by Teva Pharmaceutical Industries of Israel, also has the potential to cause involuntary movements, hallucinations and lowered blood pressure, the FDA said.
Also Wednesday, an outside panel of experts recommended that a drug already sold to treat mild to moderate dementia in Alzheimer's disease patients be approved to help Parkinson's patients.
Exelon, also called rivastigmine, is made by Switzerland's Novartis AG.
FDA still must approve that use before Novartis can begin marketing the drug to Parkinson's patients. The agency usually follows the advice of its advisory committees.
Parkinson's disease is diagnosed in more than 50,000 people in the United States each year.
Source Date: May 18 2006
Source Publication: The Associated Press