{"id":45234,"date":"2022-06-18T02:01:35","date_gmt":"2022-06-18T00:01:35","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/acadia-pharmaceuticals-announces-outcome-of-fda-advisory-committee-for-nuplazid-pimavanserin-for-the-treatment-of-alzheimers-disease-psychosis\/"},"modified":"2022-06-18T02:01:35","modified_gmt":"2022-06-18T00:01:35","slug":"acadia-pharmaceuticals-announces-outcome-of-fda-advisory-committee-for-nuplazid-pimavanserin-for-the-treatment-of-alzheimers-disease-psychosis","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/acadia-pharmaceuticals-announces-outcome-of-fda-advisory-committee-for-nuplazid-pimavanserin-for-the-treatment-of-alzheimers-disease-psychosis\/","title":{"rendered":"Acadia Pharmaceuticals Announces Outcome of FDA Advisory Committee for NUPLAZID\u00ae (pimavanserin) for the Treatment of Alzheimer\u2019s Disease Psychosis"},"content":{"rendered":"
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SAN DIEGO–(BUSINESS WIRE)–Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced the outcome of the U.S. Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) meeting for pimavanserin for the treatment of hallucinations and delusions associated with Alzheimer\u2019s disease psychosis (ADP). The PDAC voted 9 to 3 that the evidence presented does not support a conclusion that pimavanserin is effective for the treatment of hallucinations and delusions in the ADP population.\n<\/p>\n

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\n\u201cWe are disappointed with the outcome of today\u2019s vote. We will continue to work closely with the FDA as it completes its review of the totality of our efficacy and safety data to enable a full assessment of pimavanserin\u2019s benefit-risk in patients with ADP,\u201d said Steve Davis, Chief Executive Officer. \u201cWe continue to believe there is substantial evidence across multiple independent clinical studies and endpoints that support the efficacy of pimavanserin in ADP. There are no FDA approved treatments for this critical public health need and off-label use of multi-receptor acting antipsychotics have demonstrated poor patient outcomes, including worsening of cognition and motor function.\u201d\n<\/p>\n

\nThe FDA asked the PDAC today for advice and recommendations regarding the evidence that pimavanserin is effective for the treatment of hallucinations and delusions associated with ADP. The FDA is not bound by the PDAC\u2019s recommendations, but takes its advice into consideration when making decisions on drug applications. The FDA\u2019s target action date is August 4, 2022.\n<\/p>\n

\nNUPLAZID was approved in the U.S. in 2016 as the first and only treatment for hallucinations and delusions associated with Parkinson\u2019s disease psychosis (PDP). The totality of clinical trial, post-marketing and observational real-world evidence continue to support a positive benefit-risk profile for NUPLAZID for the treatment of hallucinations and delusions associated with PDP.\n<\/p>\n

\nAbout Alzheimer\u2019s Disease Psychosis<\/i>\n<\/p>\n

\nAccording to the Alzheimer\u2019s Association, approximately six million people in the United States are living with Alzheimer\u2019s disease <\/sup>(AD).1-2<\/sup> Approximately 30% of patients with AD experience psychosis, commonly consisting of hallucinations and delusions.3<\/sup> These symptoms may be frequent and severe and may recur over time.4<\/sup> 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<\/sup> There is no FDA approved drug for the treatment of Alzheimer\u2019s disease psychosis.\n<\/p>\n

\nAbout Pimavanserin<\/i>\n<\/p>\n

\nPimavanserin is a selective serotonin inverse agonist and antagonist preferentially targeting 5-HT2A <\/sub>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\u2019s disease psychosis by the U.S. Food and Drug Administration in April 2016 under the trade name NUPLAZID\u00ae<\/sup>. NUPLAZID is not approved for Alzheimer\u2019s disease psychosis. In addition, Acadia is developing pimavanserin in other neuropsychiatric conditions.\n<\/p>\n

\nAbout Acadia Pharmaceuticals<\/i>\n<\/p>\n

\nAcadia is advancing breakthroughs in neuroscience to elevate life. For more than 25 years we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only approved therapy for hallucinations and delusions associated with Parkinson\u2019s disease psychosis. Our late-stage development efforts are focused on treating psychosis in patients with dementia, the negative symptoms of schizophrenia and Rett syndrome. Our early-stage development efforts are focused on novel approaches to pain management, cognition and neuropsychiatric symptoms in central nervous system disorders. For more information, visit us at www.acadia.com<\/a> and follow us on LinkedIn<\/a> and Twitter<\/a>.\n<\/p>\n

\nImportant Safety Information and Indication for NUPLAZID\u00ae<\/sup> (pimavanserin)<\/b>\n<\/p>\n

\nIndication<\/b>\n<\/p>\n

\nNUPLAZID is indicated for the treatment of hallucinations and delusions associated with Parkinson\u2019s disease psychosis.\n<\/p>\n

\nImportant Safety Information<\/b>\n<\/p>\n

\nWARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS<\/b>\n<\/p>\n