FDA approves Nuplazid for psychosis in Parkinson’s disease
The FDA recently approved Nuplazid for hallucinations and delusions among individuals with Parkinson’s disease.
Efficacy of Nuplazid (pimavanserin, Acadia Pharmaceuticals Inc.) was indicated in a 6-week clinical trial among 199 participants. Compared with placebo, pimavanserin decreased frequency and severity of hallucinations and delusions without worsening primary motor symptoms of Parkinson’s disease.
The most common side effects were swelling in the ankles, legs and feet due to peripheral edema, nausea and confusion.
Nuplazid has a boxed warning that indicates an increased risk for death associated with use of atypical antipsychotics in older individuals with dementia-related psychosis.
“Hallucinations and delusions can be profoundly disturbing and disabling,” Mitchell Mathis, MD, director of the division of psychiatry products at the FDA’s Center for Drug Evaluation and Research, said in a press release. “Nuplazid represents an important treatment for people with Parkinson’s disease who experience these symptoms.”