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# Acadia Re-files Nuplazid sNDA for Alzheimer’s
- URL: https://www.fdaweb.com/acadia-re-files-nuplazid-snda-for-alzheimers/
- Published: 2022-02-17T12:00:00.000Z
- Updated: 2026-09-14T17:33:04.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151191

Acadia Pharmaceuticals has resubmitted a supplemental NDA for Nuplazid (pimavanserin) for treating hallucinations and delusions associated with Alzheimer’s disease psychosis (ADP). The move follows a 4/2/2021 FDA complete response letter that, at the time, the company said “cited a lack of statistical significance in some of the subgroups of dementia, and insufficient numbers of patients with certain less common dementia subtypes as lack of substantial evidence of effectiveness to support approval.” It provides additional analyses from two previously conducted clinical studies, HARMONY and Study -019, Acadia says.

The HARMONY study, Acadia contends, met its prespecified primary and secondary endpoints with “robust and persuasive clinical and statistical superiority of pimavanserin over placebo,” which it describes as a prospectively agreed prerequisite for the ADP indication. “Statistical separation by dementia subgroups and certain minimum numbers of patients with specific subtypes were not among the prespecified requirements,” it says.  

Nuplazid was approved in the U.S. in 2016 as the first treatment for hallucinations and delusions associated with Parkinson’s disease psychosis. It is described as a selective serotonin inverse agonist and antagonist that targets 5-HT2A receptors, which are believed to play an important role in psychosis, schizophrenia, depression and other neuropsychiatric disorders.