Pimavanserin on April 29 became the first drug to receive approval from the Food and Drug Administration for the indication of hallucinations and delusions associated with psychosis in Parkinson’s disease.
The drug, to be marketed under the brand name Nuplazid by Acadia Pharmaceuticals, was shown in a 6-week clinical trial of 199 participants to be superior to placebo in decreasing the frequency and/or severity of hallucinations and delusions without worsening the primary motor symptoms of Parkinson’s disease.
The most common side effects reported from the clinical trial included peripheral edema, nausea, and confused state of mind.
“Nuplazid represents an important treatment for people with Parkinson’s disease who experience these symptoms,” said Dr. Mitchell Mathis, director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research.
The FDA gave pimavanserin a Boxed Warning in relation to the general increased risk of death associated with the use of atypical antipsychotic drugs to treat older people with dementia-related psychosis. No other drug atypical antipsychotic drug has been approved to treat patients with dementia-related psychosis.
Read the agency’s full statement on the FDA website .
