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FDA Sets Date to Review Pimavanserin, an Alzheimer Disease Psychosis Therapy
The US Food and Drug Administration (FDA) plans to review the resubmitted supplemental New Drug Application (sNDA) from Acadia Pharmaceuticals Inc. for pimavanserin, a drug used for the treatment of hallucinations and delusions associated with Alzheimer disease psychosis (ADP), on August 4, 2022. The FDA also plans to hold an Advisory Committee meeting alongside the review to discuss the application.
“With no FDA approved drug to treat [Alzheimer] disease psychosis, the hallucinations and delusions that [Alzheimer] patients endure represent a highly significant unmet need, dramatically altering the lives of both [Alzheimer] patients and their caregivers,” said Acadia Pharmaceuticals Chief Executive Officer, Steve Davis, in a press release.
In April of 2016, the FDA approved NUPLAZID®(pimavanserin) for the treatment of hallucinations and delusions associated with Parkinson disease psychosis. Acadia says they are developing the drug for use in other neuropsychiatric conditions.
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Pimavanserin is a selective serotonin 5-HT2A receptor inverse agonist, the receptors “thought to play an important role in neuropsychiatric disorders.”
Over 6 million people are currently diagnosed with Alzhiemer disease and 30% of those patients experience psychosis involving hallucinations and delusions.
“We look forward to advancing our resubmission through the review process and potentially bringing this important new therapy to these families,” Davis said.
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