A phase 3 trial evaluating pimavanserin (Acadia) for the treatment of dementia-related psychosis has been stopped early due to positive findings in a planned interim efficacy analysis.
The HARMONY trial (N=356) was evaluating the safety and efficacy of pimavanserin, an atypical antipsychotic, in preventing a relapse of psychotic symptoms in patients with dementia-related psychosis who were stabilized after 12 weeks of open-label pimavanserin treatment.
Patients included in the study met the clinical criteria for one of the following disorders: Parkinson disease dementia, Lewy body dementia, possible or probable Alzheimer disease dementia, vascular dementia or frontotemporal degeneration spectrum disorders. The primary end point of the study was time to relapse in the double-blind period; relapse was defined as significant worsening of dementia-related psychosis after prior stabilization.
Results showed that pimavanserin treatment was associated with a statistically significant longer time to relapse of dementia-related psychosis compared with placebo. These findings led the study’s independent data monitoring committee to recommend stopping the trial early.
Acadia plans to submit a supplemental New Drug Application (sNDA) for this indication with the Food and Drug Administration (FDA) in 2020. If approved, pimavanserin would be the first treatment specifically indicated for dementia-related psychosis.
Pimavanserin (Nuplazid) is currently approved for the treatment of hallucinations and delusions associated with Parkinson disease psychosis.
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