On 5 April, Acadia Pharmaceuticals Inc, announced that the company has received the decision from the US Administration Food and Drug Administration (FDA) regarding 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 letter from FDA stating that the application cannot be approved. The FDA did not mention any safety issues, it raised concerns regarding statistically significant data in some of the subgroups of dementia and insufficient numbers of participants with certain less common dementia subtypes. Acadia Pharmaceuticals will request a meeting with the FDA to address the concerns and determine the next steps for potential approval of pimavanserin in dementia-related psychosis.
