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# FDA Tells Acadia that Nuplazid sNDA has Deficiencies
- URL: https://www.fdaweb.com/fda-tells-acadia-that-nuplazid-snda-has-deficiencies/
- Published: 2021-03-09T12:00:00.000Z
- Updated: 2026-09-14T16:50:04.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148833

FDA has told Acadia Pharmaceuticals that its ongoing review of a supplemental NDA for Nuplazid (pimavanserin), indicated for treating hallucinations and delusions associated with dementia-related psychosis, has found deficiencies that preclude labeling and post-marketing requirements/commitments discussions at this time. The agency stated that its communication about the deficiencies does not reflect a final decision on the information under review, Acadia says.  

FDA accepted the supplemental NDA for review 7/2020 and assigned a standard review with a user fee review action date of 4/2/2021\. Acadia said at the time that the submission was based on data from 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 included a large safety database from completed and ongoing studies representing over 1,500 patients with neurodegenerative disease. Nuplazid was approved in 2016 for hallucinations and delusions associated with Parkinson’s disease psychosis.