Pimavanserin is an antipsychotic drug, approved by the US Food and Drug Administration (FDA) for the treatment of Parkinson's disease psychosis, which could soon be expanded for dementia-related psychosis. On 9 September, ACADIA Pharmaceuticals announced positive results from its Phase III HARMONY trial of pimavanserin aiming to evaluate the efficacy and safety of pimavanserin by comparing it with placebo in preventing a relapse of psychotic symptoms in people with dementia-related psychosis.
HARMONY was designed as a double-blind and placebo-controlled trial enrolling people with dementia-related psychosis in US and Europe. After an open-label stabilisation period of 12 weeks where participants received pimavanserin once daily, they were randomised to continue their pimavanserin dose or switched to a placebo control. Participants were then followed for up to 26 weeks or until a relapse of psychosis occurred. For the purpose of the study, relapse was defined as hospitalisation due to dementia-related psychosis, deterioration of symptoms, withdrawal from the study due to lack of efficacy, or the use of anti-psychotic medications.
The drug met its primary endpoint of delaying relapse of psychosis in people with dementia-related psychosis compared to placebo in a planned interim efficacy analysis. Upon the recommendations of the independent data monitoring committee based on statistical criteria of positive efficacy, Acadia Pharmaceuticals said that it would end the study early. Results will be presented at upcoming conferences. ACADIA Pharmaceuticals is planning to initiate discussions with the FDA regarding a regulatory pathway to approve this indication for the treatment of dementia-related psychosis. There is currently no FDA-approved drug for the treatment of dementia-related psychosis and if approved, pimavanserin would be the first one.
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