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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
The Food and Drug Administration Plans to Hold Advisory Committee Meeting SAN DIEGO--(BUSINESS WIRE)-- Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) announced
About this update from Acadia Pharmaceuticals Inc.
[{"type":"text","content":"\nThe Food and Drug Administration Plans to Hold Advisory Committee Meeting\n\n SAN DIEGO--(BUSINESS WIRE)--\nAcadia Pharmaceuticals Inc. (Nasdaq: ACAD) announced today that it has received a target action date of August 4, 2022 from the U.S. Food and Drug Administration (FDA) for its resubmitted supplemental New Drug Application (sNDA) for pimavanserin for the treatment of hallucinations and delusions associated with Alzheimer’s disease psychosis (ADP). The FDA’s Division of Psychiatry has also advised the company that it is planning to hold an Advisory Committee meeting in connection with its review.\n\n“We look forward to working with the Division 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. We look forward to advancing our resubmission through the review process and potentially bringing this important new therapy to these families.”\n\nAbout Alzheimer’s Disease Psychosis\nAccording to the Alzheimer’s Association, approximately six million people in the United States are living with Alzheimer’s disease (AD).1-2 Approximately 30% of patients with AD experience psychosis, commonly consisting of hallucinations and delusions.3 These symptoms may be frequent and severe and may recur over time.4 A hallucination is defined as a perception-like experience that occurs without an external stimulus and is sensory (seen, heard, felt, tasted, sensed, smelled) in nature. A delusion is defined as a false, fixed belief despite evidence to the contrary. Serious consequences have been associated with psychosis in patients with dementia, such as increased likelihood of nursing home placement, more severe dementia, and increased risk of morbidity and mortality.5-6 There is no FDA-approved drug for the treatment of Alzheimer’s disease psychosis.\n\nAbout Pimavanserin\nPimavanserin is a selective serotonin inverse agonist and antagonist preferentially targeting 5-HT2A receptors. These receptors are thought to play an important role in neuropsychiatric disorders. In vitro, pimavanserin demonstrated no apprec...