The publication (https://link.springer.com/article/10.14283/jpad.2018.30) focused on the pre-specified analysis in the subgroup of patients who had more pronounced psychotic symptoms at baseline. In this subgroup of patients with more severe delusions and hallucinations, at the primary efficacy endpoint, pimavanserin demonstrated significant improvement relative to placebo with a similar and acceptable tolerability profile. These results were also presented recently at the Alzheimer’s
“The robust efficacy of pimavanserin in patients with more severe psychotic symptoms is relevant to the therapeutic benefits of pimavanserin in a patient population with Alzheimer’s disease and psychosis,” said lead investigator
A separate review published in JPAD (https://link.springer.com/article/10.14283/jpad.2018.29) also supports the potential use of pimavanserin in other forms of neurodegenerative diseases, including dementia-related psychosis. A research group led by
ACADIA is currently conducting the Phase 3 HARMONY study in dementia-related psychosis. This is a randomized withdrawal study designed to evaluate the efficacy of pimavanserin in preventing relapse of psychotic symptoms in patients with dementia-related psychosis. Patients whose dementia-related hallucinations and delusions respond to 12 weeks of open-label treatment with pimavanserin are randomized, in a double-blinded manner to continue pimavanserin therapy or to placebo. The primary endpoint of this study is the average time to relapse between pimavanserin and placebo. Studies suggest that 30% of patients with dementia have psychosis, commonly consisting of hallucinations and delusions. Serious consequences have been associated with severe or persistent psychosis in patients with dementia. These consequences can impact both patients and their families. Medications that are currently used off-label to treat dementia related psychosis have been shown to impair cognition in this already impaired population.
ACADIA is a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders. ACADIA has developed and is commercializing the first and only medicine approved for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis. In addition, ACADIA has ongoing clinical development efforts in additional areas with significant unmet need including dementia-related psychosis, schizophrenia inadequate response, schizophrenia-negative symptoms, major depressive disorder and Rett syndrome. This press release and further information about ACADIA can be found at: www.acadia-pharm.com.
Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements include, but are not limited to, statements related to the potential benefits of pimavanserin in patients with dementia-related psychosis. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in drug discovery, development, approval and commercialization, and the fact that past results of clinical trials may not be indicative of future trial results. For a discussion of these and other factors, please refer to ACADIA’s annual report on Form 10-K for the year ended