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Parkinson's Disease Drug Azilect Approved By FDA - Treatment For Early Stage and Late State with Levodopa -  Side Effects

May 17th 2006

Parkinson's Disease Drug Azilect Approved By FDA - Treatment For Early Stage and Late State with Levodopa -  Side Effects

Health

The Food and Drug Administration (FDA) approved a new drug by Israeli drug maker Teva Pharmaceutical Industries in Tel Aviv for the treatment of Parkinson’s disease.  The molecular identity is called Azilect (rasagiline) and is a monoamine oxidase type--B (MAO-B) inhibitor that blocks the breakdown of dopamine.  Dopamine is a chemical that sends information to the parts of the brain that control movement and coordination.

The drug has been approved for both early and late stages of the disease. Azilect was approved for use as an initial single drug therapy in early Parkinson's disease, and as an addition to levodopa for advanced stages.  Levodopa has been a standard treatment for Parkinson’s disease. 

 

Dr. Steven Galson said "This is a welcome development for the more than 50,000 Americans who are each year diagnosed with Parkinson's disease.  Parkinson's is a relentless disease with limited treatment options, and each new therapy is an important addition to the physicians' treatment options."  Galson is Director of the Center for Drug Evaluation and Research. 

According to the FDA, the safety and efficacy was demonstrated in three 18- to 26-week controlled clinical trials.  The first study compared the effects of Azilect with the effects of placebo in 404 patients with early Parkinson's disease.  The patients who took 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.

 

Levodopa was added to Azilect in the other two studies.  The effects of Azilect with placebo when taken together with levodopa by over 1100 patients with more advanced Parkinson's.  They found that patients who took the combination therapy had significantly less time per day with relatively poor function and mobility as compared with patients on levodopa and placebo.

The FDA report says that patients who also consume tyramine-rich foods, beverages (such as cheese and red wine) or dietary supplements or amines contained in many cough/cold medications may have a “hypertensive crisis”.  They say patients will need to avoid these sources of tyramine and amines when taking Azilect. 

 

The FDA warns that most Parkinson’s drugs, including Azilect have the potential to cause involuntary movements (dyskinesias), hallucinations and lowered blood pressure.  These side effects are described in the product labeling.

Also, during development, melanoma 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 disease have an increased risk for this form of skin cancer.  In order to address the question of whether or not Azilect itself increases such risk, the drug's manufacturer will perform a Phase 4 (postmarket) study. The product labeling will recommend that patients undergo periodic dermatologic examinations.

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Dan Wilson
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Copyright 2005 Best Syndication                   Last Updated Saturday, July 10, 2010 09:51 PM