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# Acadia sNDA for Dementia-related Hallucinations
- URL: https://www.fdaweb.com/acadia-snda-for-dementia-related-hallucinations/
- Published: 2020-07-20T12:00:00.000Z
- Updated: 2026-09-14T16:21:46.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147231

FDA has accepted for review an Acadia Pharmaceuticals supplemental NDA for Nuplazid (pimavanserin) for treating hallucinations and delusions associated with dementia-related psychosis. The agency has assigned a standard review with a user fee review action date of 4/2/2021\. The sNDA is based on data from a the pivotal Phase 3 HARMONY study, which met its primary endpoint — demonstrating that pimavanserin significantly reduced the risk of relapse of psychosis by 2.8 fold compared to placebo. It also includes a large safety database from completed and ongoing studies representing over 1,500 patients with neurodegenerative disease, the company says. Nuplazid was approved in 2016 for hallucinations and delusions associated with Parkinson’s disease psychosis.