The U.S. Food and Drug Administration (FDA) approved the use of Nuplazid (pimavanserin) to treat Parkinson's disease patients last week.
Nuplazid is the first drug approved to treat the hallucinations and delusions
that some Parkinson's patients experience. Nuplazid is marketed by Acadia Pharmaceuticals Inc.
Up to 50 percent of Parkinson's disease patients suffer from hallucinations and delusions. The patients may become extremely impaired and unable to care for themselves. They may also develop false beliefs that interfere with their ability to communicate with loved ones.
“Hallucinations and delusions can be profoundly disturbing and disabling,” FDA’s Center for Drug Evaluation and Research Director of the Division of Psychiatry Products Dr. Mitchell Mathis said. “Nuplazid represents an important treatment for people with Parkinson’s disease who experience these symptoms.”
A six-week clinical trial of 199 patients tested the effectiveness of Nuplazid versus a placebo. Nuplazid reduced the psychotic symptoms without affecting the motor symptoms of Parkinson's disease.
Nuplazid received breaththrough therapy designation, which expedites development and review of new drugs. It was also placed in the priority review program. It provides a substantial improvement over the currently available treatments for Parkinson's patients suffering from psychotic symptoms.
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