FDA Updates Nuplazid Label to Clarify Medication’s Indication

The Food and Drug Administration (FDA) has updated the label for Nuplazid (pimavanserin; Acadia Pharmaceuticals, San Diego, CA) with revisions to the boxed warning and clinical studies sections for this atypical antipsychotic. The changes are intended to clarify that Nuplazid is used to treat people with hallucinations and delusions related to Parkinson disease (PD), with or without dementia. Nuplazid received its initial FDA approval in 2016, and the new updates are consistent with its current indication.

The FDA made 2 changes to Nuplazid’s label:

1. The clinical studies section of Nuplazid’s prescribing information was updated to emphasize that the phase 3 study leading to the medication’s FDA approval included participants with or without dementia.

2. Nuplazid’s boxed warning was revised to clarify that the medication is only approved to treat people with PD-related hallucinations and delusions, with or without dementia.

"This update makes it clear that NUPLAZID can be prescribed to treat patients with Parkinson’s disease psychosis, with or without dementia," said Jeffrey Cummings, MD, ScD, Director of the Chambers-Grundy Center for Transformative Neuroscience at the University of Nevada.