The Food and Drug Administration (FDA) is expected to make a decision on the supplemental New Drug Application (sNDA) for pimavanserin for the treatment of hallucinations and delusions associated with Alzheimer disease psychosis on August 4, 2022. An FDA advisory committee meeting is being planned to discuss the application.

Acadia Pharmaceuticals resubmitted the sNDA after addressing issues raised in a Complete Response Letter issued by the Agency.  The Company provided additional analyses from the HARMONY (ClinicalTrials.gov Identifier: NCT03325556) and Study-019 (ClinicalTrials.gov Identifier: NCT02035553) trials in the resubmitted application to support the new indication.

Pimavanserin, an atypical antipsychotic, is currently marketed under the brand name Nuplazid® and is approved for the treatment of hallucinations and delusions associated with Parkinson disease psychosis. There is currently no FDA-approved treatment for Alzheimer disease psychosis.

“We look forward to working with the [FDA’s Division of Psychiatry] during the course of their review and in preparation for the advisory committee meeting,” said Steve Davis, Chief Executive Officer. “With no FDA approved drug to treat Alzheimer’s disease psychosis, the hallucinations and delusions that Alzheimer’s patients endure represent a highly significant unmet need, dramatically altering the lives of both Alzheimer’s patients and their caregivers.”

Reference

Acadia Pharmaceuticals announces August 4, 2022 action date for resubmitted supplemental New Drug Application for Nuplazid® (pimavanserin) for the treatment of Alzheimer’s disease psychosis. News release. Acadia Pharmaceuticals. Accessed March 9, 2022. https://www.businesswire.com/news/home/20220309005324/en/Acadia-Pharmaceuticals-Announces-August-4-2022-Action-Date-for-Resubmitted-Supplemental-New-Drug-Application-for-NUPLAZID%C2%AE-pimavanserin-for-the-Treatment-of-Alzheimer%E2%80%99s-Disease-Psychosis