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May 18, 2006 -- The FDA has approved the drug Azilect (rasagiline) for the treatment of Parkinson's diseaseParkinson's disease.
The drug is a new molecular entity. Specifically, it?s a monoamine oxidase type-B (MAO-B) inhibitor that blocks the breakdown of dopamine, a chemical that is important in normal neurologic function.
Parkinson's disease is a chronic, progressive neurodegenerative condition in which brain cells that produce dopamine are destroyed. As a result, dopamine levels fall, and the brain?s movement instructions to the body are delivered more slowly, leaving people incapable of initiating and controlling movements normally.
Azilect?s approval ?is a welcome development for the more than 50,000 Americans who are each year diagnosed with Parkinson's disease,? says Steven Galson, MD, MPH, in an FDA news release. Galson directs the FDA?s 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,? Galson says.
Drug?s Use, Trials
The FDA approved Azilect for use as an initial single drug therapy in early Parkinson's disease, and as an addition to another drug, levodopa, in more advanced patients. Levodopa is a standard treatment for Parkinson's disease.
Azilect?s safety and effectiveness were 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. Placebos don?t contain medicine; they?re used in studies for comparison purposes.
The FDA reports that 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.
The other two studies compared the effects of Azilect with placebo when taken together with levodopa by more than 1,100 patients with more advanced Parkinson's.
In those studies, patients using Azilect together with levodopa had significantly less time per day with relatively poor function and mobility as compared with patients on levodopa and placebo, according to the FDA.
Drug?s Cautions
Azilect may be associated with dangerously high blood pressurehigh blood pressure (hypertensive crisis) if patients also consume items rich in tyramine and amines.
Tyramine sources include foods and beverages (such as cheese and red wine) and some dietary supplements; amines are contained in many cough/cold medications, according to the FDA.
?Therefore, patients will need to avoid these sources of tyramine and amines when taking Azilect,? states the FDA?s news release.
As with most other medications for Parkinson's, Azilect has the potential to cause involuntary movements (dyskinesias), hallucinations, and lowered blood pressure. These side effects are described in the product labeling.
During development, melanomamelanoma (a form of skin cancerskin cancer) was diagnosed in a small number of patients treated with Azilect. Although the FDA has concluded that the available data do not establish that Azilect is associated with an increased risk for melanoma, it appears that compared to the general population, patients with Parkinson's diseaseParkinson's disease have an increased risk for this form of skin cancercancer.
In order to address the question of whether or not Azilect itself increases such risk, the drug's manufacturer will perform a phase IV (post-market) study. The product labeling will recommend that patients undergo periodic dermatologic examinations.
Azilect is made by Teva Pharmaceutical Industries in Tel Aviv, Israel.
SOURCE: News release, FDA.