On 8 March, Acadia Pharmaceuticals Inc, announced a regulatory update on its supplemental new drug application for pimavanserin for the treatment of hallucinations and delusions associated with dementia-related psychosis. Pimavanserin is an antipsychotic drug, approved by the US Food and Drug Administration (FDA) for the treatment of Parkinson's disease psychosis. The FDA has accepted the filing of the supplemental new drug application for pimavanserin in July 2020 for the treatment of hallucinations and delusions associated with dementia-related psychosis. 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 drug met its primary endpoint of delaying relapse of psychosis in people with dementia-related psychosis compared to placebo.
The company announced that it received a notification from FDA stating the identification of deficiencies that preclude discussion of labelling and further steps in the approval process of pimavanserin as a possible treatment of dementia-related psychosis. The FDA stated that this notification does not reflect a final decision on the information under review, but likely reflects a need for more information. The company plans to work with the FDA to learn the nature of the deficiencies and seek to resolve them.
