FDA Approves Neupro Patch for Parkinson's Disease

Parkinson's disease (PD) is a debilitating illness that results from the loss of dopamine- producing brain cells. The disease affects more than 1.5 million people Americans, with around 60,000 new cases diagnosed each year. What is a timely celebration of the National Parkinson Foundation's 50^th anniversary where "Hope is Golden," the U.S. Food and Drug Administration (FDA) announced that it has approved the Neupro Patch to treat early symptoms of Parkinson's disease. The Neupro Patch contains rotigotine, which belongs to the dopamine agonist class of drugs. It has not previously been approved for use in the United States.

Schwartz Bioscience, located at Research Triangle Park in North Carolina, manufactures the Neupro Patch. The silicone-based patch, replaced every 24 hours, will continuously deliver doses of rotigotine through the skin. The rotigotine works by activating dopamine receptors in the body, mimicking the effects of the neurotransmitter dopamine. Studies done during the approval process included 1,154 patients with early Parkinson's disease who were not taking other medications for Parkinson's disease.

The most common side effects of the Neupro Patch included skin reactions at the patch site, dizziness, nausea, vomiting, drowsiness and insomnia. Almost all of these symptoms are common when using this class of drug. Some of the potential safety concerns that should be noted are sleepiness, hallucinations, and decreased blood pressure while standing.

Parkinson's disease is both chronic and progressive, meaning that it persists over a long period of time and it gets worse with time. Some people become severely disabled while others experience only minor disruptions in their motor skills. The four most common symptoms of Parkinson's disease are tremor, stiffness of limbs, slowness in movement, and impaired balance and coordination. As the disease progresses, some patients may experience trouble talking or completing simple tasks. Other symptoms could include depression, emotional changes, sleep disruptions, difficulty with chewing and swallowing, and urinary problems or constipation. Parkinson's disease usually affects people over the age of 50, but has been diagnosed in younger patients, as was the case with actor Michael J. Fox.

Previously, the FDA approved a therapy called deep brain stimulation where electrodes are implanted in the brain and connected to a pulse generator that can be externally programmed. The therapy requires careful programming in order to work correctly, but has been shown to reduce tremors, slowness of movement, and gait problems. No one can predict which symptoms an individual patient will have, and the severity of the symptoms vary from patient to patient. FDA's approval of the Neupro Patch is a welcome alternative to those people afflicted with Parkinson's disease.

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