Rasagiline and Parkinson's Disease
FDA Approves New Treatment for Parkinson's Disease
The Food and Drug Administration today approved Azilect (rasagiline), a new molecular entity, for the treatment of Parkinson's disease. The drug is a monoamine oxidase type--B (MAO-B) inhibitor that blocks the breakdown of dopamine, a chemical that sends information to the parts of the brain that control movement and coordination.
"This is a welcome development for the more than 50,000 Americans who are each year diagnosed with Parkinson's disease, " said Dr. Steven Galson, Director of the Center for Drug Evaluation and Research. "Parkinson's is a relentless disease with limited treatment options, and each new therapy is an important addition to the physicians' treatment options."
Azilect was approved for use as an initial single drug therapy in early Parkinson's disease, and as an addition to levodopa in more advanced patients. Levodopa is a standard treatment for Parkinson's disease. The safety and effectiveness of Azilect was demonstrated in three 18- to 26-week controlled clinical trials.
One of the studies compared the effects of Azilect with the effects of placebo in 404 patients with early Parkinson's. Compared with patients on placebo, the condition of patients on Azilect showed significantly less worsening on a rating scale that measures the ability to perform mental and motor tasks as well as daily living activities.
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Anthony H. Risser | neuroscience | neuropsychology | brain