FDA Approves 1st Parkinson's Patch
Once-Daily Skin Patch, Called Neupro, Treats Early Symptoms of Parkinson's Disease
May 9, 2007 -- The FDA today announced the approval of Neupro, the first skin patch designed to treat symptoms of early Parkinson's disease.
In a healthy brain, certain brain cells produce a chemical called dopamine, which helps the brain coordinate the body's movements. In Parkinson's disease, dopamine-producing brain cells falter and die.
Parkinson's disease progresses gradually. Its four main symptoms are trembling in the hands, arms, leg, jaw, and face; stiffness of the limbs and trunk; slowness of movement; and impaired balance and coordination. As these symptoms become more pronounced, patients may have difficulty walking, talking, or completing simple tasks.
Neupro patches, which are changed daily, deliver a new drug called rotigotine through the skin. Rotigotine is a member of a class of drugs called dopamine agonists, which mimic dopamine's effects.
Other Parkinson's disease drugs are given orally. Those drugs are effective, but some patients experience a wearing-off effect at the end of each dose. The Parkinson's patch is designed to solve that problem.
The FDA says Neupro's effectiveness was demonstrated in three studies that included 1,154 patients with early Parkinson's disease who were not taking other Parkinson's medications.
The most common side effects in clinical trials included skin reactions at the patch site, dizziness, nausea, vomiting, drowsiness, and insomnia. Most of those side effects are typical for this class of drug, states the FDA in a news release.
Other potential safety concerns with Neupro include sudden onset of sleep while engaged in routine activities such as driving or operating machinery (sleep attacks), hallucinations, and decreased blood pressure on standing up (postural hypotension), according to the FDA.
Neupro Patch is made by Schwarz Bioscience of Research Triangle Park, N.C.