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Acadia Pharmaceuticals Announces FDA Advisory Committee Meeting to Review Resubmission of Supplemental New Drug Application for NUPLAZID® (pimavanserin) for the Treatment of Alzheimer’s Disease Psychosis Scheduled for June 17, 2022
SAN DIEGO--(BUSINESS WIRE)-- Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that a virtual meeting of the U.S. Food and Drug Administration's
About this update from Acadia Pharmaceuticals Inc.
[{"type":"text","content":" SAN DIEGO--(BUSINESS WIRE)--\nAcadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that a virtual meeting of the U.S. Food and Drug Administration's Psychopharmacologic Drugs Advisory Committee to review the resubmitted supplemental New Drug Application (sNDA) for pimavanserin for the treatment of hallucinations and delusions associated with Alzheimer’s disease psychosis (ADP) has been scheduled for June 17, 2022. The target action date for the application is August 4, 2022.\n\n“We appreciate our ongoing engagement with the FDA and look forward to a productive discussion on the clinical evidence supporting the positive benefit-risk profile for pimavanserin as a treatment for ADP at the upcoming Advisory Committee meeting,” said Steve Davis, Chief Executive Officer. “The hallucinations and delusions that Alzheimer’s patients endure represent one of the most significant burdens in this community, and one of the leading reasons for long-term care placement. There are no FDA-approved treatments for this critical public health need. Off-label use of multi-receptor acting antipsychotics with marginal efficacy and significant safety concerns can lead to poor patient outcomes, including worsening of cognition and motor function.”\n\nAbout Alzheimer’s Disease Psychosis\n\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\n\nPimavanserin is a selective serotonin inverse agonist and antagonist preferentially targeting 5-HT2A receptors. These receptors are thought to play an important role in neuropsychiatri...