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# Advisors to Consider Acadia’s Nuplazid for Alzheimer’s Psychosis
- URL: https://www.fdaweb.com/advisors-to-consider-acadias-nuplazid-for-alzheimers-psychosis/
- Published: 2022-06-15T12:00:00.000Z
- Updated: 2026-09-14T17:48:53.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152082

Members of FDA’s Psychopharmacologic Drugs Advisory Committee will meet on 6/17 to consider Acadia Pharmaceutical’s resubmitted sNDA for Nuplazid (pimavanserin) for an indication to treat hallucinations and delusions associated with Alzheimer’s disease psychosis. The agency issued a [briefing document](https://www.fda.gov/media/159249/download?ref=fdaweb.com) in advance of the meeting indicating committee members will be asked to: 

- discuss whether the evidence supports the effectiveness of Nuplazid for the proposed indication, including the strengths and limitations of the submitted studies and the drug’s current indication for treating hallucinations and delusions associated with Parkinson’s disease psychosis; and
- discuss whether the available evidence supports a conclusion that Nuplazid is effective for the proposed indication.

The briefing document says the agency does not have a key safety issue to bring before the committee as the sNDA development program findings were generally consistent with the known Nuplazid safety profile.

Acadia’s initial sNDA received a complete response letter suggesting a lack of statistical significance in some dementia subgroups. FDA says additional analyses provided by the company met the requirement to consider the drug for the proposed Alzheimer’s indication.