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Acadia Pharmaceuticals Announces Resubmission of Supplemental New Drug Application to U.S. FDA for NUPLAZID® (pimavanserin) to Treat Alzheimer’s Disease Psychosis
SAN DIEGO--(BUSINESS WIRE)-- Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) announced today that it has resubmitted its supplemental New Drug Application (sNDA)
About this update from Acadia Pharmaceuticals Inc.
[{"type":"text","content":" SAN DIEGO--(BUSINESS WIRE)--\nAcadia Pharmaceuticals Inc. (Nasdaq: ACAD) announced today that it has resubmitted its supplemental New Drug Application (sNDA) for pimavanserin for the treatment of hallucinations and delusions associated with Alzheimer’s disease psychosis (ADP) to the U.S. Food and Drug Administration (FDA).\n\nThis resubmission is in response to the FDA’s April 2, 2021 Complete Response Letter (CRL) to the sNDA originally submitted for a proposed indication for pimavanserin for the treatment of dementia-related psychosis. The resubmission provides additional analyses from two previously conducted clinical studies, HARMONY1 and Study -0192, to support a proposed indication for the treatment of ADP and is intended to address the issues raised in the FDA’s CRL.\n\nAbout Alzheimer’s Disease Psychosis\nAccording to the Alzheimer’s Association, over six million people in the United States are living with Alzheimer’s disease3 (AD). Approximately 30% of patients with AD experience psychosis, commonly consisting of hallucinations and delusions4. These symptoms may be frequent and severe and may recur over time. A hallucination is defined as a perception-like experience that occurs without an external stimulus and is sensory (seen, heard, felt, tasted, sensed) in nature. A delusion is defined as a false, fixed belief that is resolutely held despite evidence to the contrary. Serious consequences have been associated with psychosis in patients with dementia, such as repeated hospital admissions, increased likelihood of nursing home placement, faster progression of dementia, and increased risk of morbidity and mortality5. 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 appreciable binding affinity for dopamine (including D2), histamine, muscarinic, or adrenergic receptors. Pimavanserin was approved for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis by the U.S. Food and Drug Administration in April 2016 under the trade name NUPLAZID®. NUPLAZID is not approved for Alzheimer’s disease psychosis. ...