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Acadia Pharma (ACAD) Said FDA Panel Voted Against Efficacy of NUPLAZID to Treat ADP

June 21, 2022 6:30 AM EDT

Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced Friday evening 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’s 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.

“We are disappointed with the outcome of today’s 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’s benefit-risk in patients with ADP,” said Steve Davis, Chief Executive Officer. “We 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.”

The 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’s recommendations, but takes its advice into consideration when making decisions on drug applications. The FDA’s target action date is August 4, 2022.

NUPLAZID was approved in the U.S. in 2016 as the first and only treatment for hallucinations and delusions associated with Parkinson’s 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.

About Alzheimer’s Disease Psychosis

According 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.



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