New drug for Parkinson's gets FDA approval

May 21 2006

The Food and Health Administration in the U.S. has granted approval for a new drug to treat patients with Parkinson's disease.

The drug Azilect works by blocking the breakdown of dopamine, a chemical for cellular signaling that controls muscle movement.

The breakdown of dopamine contributes to the movement and coordination problems that affect people with Parkinson's.

The drug manufacturer Teva Pharmaceutical says it can be used alone to treat the early stages of the disease or in combination with the drug levodopa during the more progressive stages.

According to U.S. health officials as many as 1.5 million Americans suffer from the chronic degenerative condition, and 50,000 new cases are diagnosed each year.

Dr. Steven Galson, head of the FDA's Center for Drug Evaluation and Research says Parkinson's is a relentless disease with limited treatment options, and each new therapy is an important addition to the physicians' treatment options.

There is at present no cure for the disease, and Azilect is the latest therapy to attempt to slow its inevitable progression.

The FDA says that in three controlled clinical trials Azilect showed significantly less worsening of the disease on a rating scale that measures the ability to perform mental and motor tasks as well as daily living activities.

However the FDA says the drug can cause dangerous reactions when patients consume food or beverages that contain a substance called tyramine.

Tyramine is found in products such as draft beer, red wine, aged cheeses, soy sauce, salamis and wine, and amines, found in many cough and cold medications.

In combination with Azilect sudden high blood pressure results and can cause stroke and death.

Patients using the medication are advised to avoid such products.

Adverse effects can also include involuntary movements, hallucinations and lowered blood pressure and in some patients an increased risk of skin tumours.

The approval was expected as the drug has already been cleared for use in several European countries.