Apokyn Approved for Treatment of Immobility in Parkinson’s Disease Patients

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FDA Approves Drug for
Parkinson’s Patients

WASHINGTON, D.C. — April 30, 2004 — The U.S. Food and Drug Administration has approved the use of Apokyn (apomorphine hydrochloride) for the treatment of immobility in Parkinson’s patients (FDA Talk Paper, April 21, 2004). Patients with advanced Parkinson’s disease may experience “off periods” during which their movement freezes and they are unable to walk, get up from a chair, or speak clearly. These episodes may occur about three to five years after diagnosis, and may be due to the wearing off of standard therapy with the drug L–dopa.

In Parkinson’s disease, brain cells that produce the neurochemical dopamine degenerate, resulting in tremors, slowed movement, shuffling gait, and loss of balance. The condition effects about 1.5 million people, including about 10% who suffer from off periods. In three clinical trials with patients who had had Parkinson’s disease for an average of 11.3 years, Apokyn stopped the off periods while they were occurring. These patients were also taking L–dopa.

Bertek Pharmaceuticals Inc., the manufacturer of Apokyn, says that the drug must be injected under the skin, and taken with certain other medications that prevent nausea and vomiting (Bartek Pharmaceuticals Newsroom, click on 4/22/04 press release). Apokyn cannot prevent the off episodes and does not replace other Parkinson’s disease medicines such as L–dopa, but rather treats an existing off episode when it occurs. It is called an “acute, rescue treatment.”

Parkinson’s Disease and Welding

Welders may be more prone to developing Parkinson’s disease because they are exposed to welding fumes, which contain toxic heavy metals such an manganese, chromium, nickel, zinc, and arsenic. A 2001 report from the University of Washington indicated that exposure to welding fumes may accelerate the onset of Parkinson’s disease (Neurology 2001 Jan 9; 56(1): 8–13). The researchers showed that some welders developed Parkinson’s disease at the early age of 46, about 17 years before most other Parkinson’s patients developed the disease. Welders may also develop manganese poisoning or manganism. This is a condition that has Parkinson–like symptoms such as tremors, gait and movement problems.

For more information about the biology and treatment of Parkinson’s disease, see the web sites of the Mayo Clinic College of Medicine, the National Parkinson Foundation, and CenterWatch (clinical trials concerning Parkinson’s disease). If you are a welder who is experiencing Parkinson–like symptoms, we urge you to consult your physician as soon as possible. For more information about your legal options, please feel free to contact us at Brayton Purcell. Although we try to provide general information, any treatment decision should be based on extensive discussions with your treating physicians. We have been handling medical/legal cases for over 20 years, including those involving exposure to toxic substances.