On 20 July, ACADIA Pharmaceuticals Inc. announced that the US Food and Drug Administration (FDA) has accepted for filing its supplemental New Drug Application for pimavanserin for the treatment of hallucinations and delusions associated with dementia-related psychosis. The application was accepted by FDA with a decision set for April 2021 This application is supported by findings from the HARMONY Phase III trial, which evaluated the safety and efficacy of pimavasenrin for the treatment of hallucinations and delusions associated with Lewy Bodies, vascular dementia and frontotemporal dementia.
The study met its primary endpoint, demonstrating that pimavanserin significantly reduced the risk of relapse of psychosis by 2.8 fold compared to placebo. Pimavanserin is an antipsychotic drug that is currently approved for Parkinson’s disease-related psychosis, under the trade name NUPLAZID. Pimavanserin functions by blocking the 5HT2a serotonin receptor and is classified as a selective serotonin inverse agonist.
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