FDA Approves Nuplazid™ for Treatment of Psychosis in Parkinson’s

The Parkinson’s Disease Foundation (PDF) alerts the community that pimavanserin (Nuplazid™) has been approved by the US Food and Drug Administration (FDA) for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis. The drug’s manufacturer, Acadia Pharmaceuticals Inc., announced the approval on April 29. Pimavanserin is the first drug indicated specifically to treat symptoms of psychosis in Parkinson’s.

During the course of the disease, people living with Parkinson’s may experience symptoms of psychosis such as hallucinations and delusions. These symptoms are not only distressing, they are also the leading reason that people with Parkinson’s enter nursing homes. Unfortunately, most drugs available to treat psychosis also worsen Parkinson’s symptoms due to the way the drugs work in the brain (by blocking the chemical messenger dopamine). Pimavanserin works differently — targeting a different area of the brain and blocking receptors for a different chemical messenger called serotonin.

The manufacturer states that the drug approval is based on data from several clinical studies, including one published in The Lancet, which found that among participants taking the drug over a six week period, pimavanserin decreased the frequency or severity of hallucinations and delusions without worsening the primary motor symptoms of Parkinson’s. The manufacturer reports possible side effects and interactions, which include nausea, confusion and increased risk for death among elderly individuals with dementia-related psychosis.

“Right now, there are few options available for the treatment of hallucinations and delusions in Parkinson’s, and the treatments that are available are often suboptimal or require frequent blood tests to check for toxicity,” says Kathleen M. Shannon, M.D., Chair of PDF’s Medical Policy Committee and Professor of Neurological Sciences at Rush Medical College. “Placebo-controlled clinical trials of pimavanserin have demonstrated significant improvements in psychiatric symptoms, sleep and daytime wakefulness in people with Parkinson’s and decreased burden on caregivers. Studies also show no association with worsening of movement symptoms. Overall, it may be a valuable new treatment for a very difficult problem in Parkinson’s.”

 

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