The Food and Drug Administration (FDA) has accepted for filing the supplemental New Drug Application (sNDA) for pimavanserin (Nuplazid®; Acadia) for the treatment of hallucinations and delusions associated with dementia-related psychosis.
The sNDA is supported by efficacy and safety data from the double-blind, phase 3 HARMONY trial that compared pimavanserin, an atypical antipsychotic, to placebo in the treatment of hallucinations and delusions associated with dementia-related psychosis. After a 12 week open-label stabilization period, 351 patients were randomized into a double-blind period to continue pimavanserin or switch to placebo, and followed for up to 26 weeks or until a relapse of psychosis occurred.
Findings showed that pimavanserin met the primary end point achieving a significant reduction in the risk of relapse by 2.8-fold in the double-blind period compared with placebo (hazard ratio [HR] 0.353; one-sided P =.0023). Moreover, pimavanserin was associated with a significant reduction in the risk of discontinuation for any reason by 2.2 fold (HR 0.452; one-sided P =.0024).
With regard to safety, pimavanserin was found to be well tolerated and was not associated with a decline in cognition (as measured by the Mini-Mental State Examination score), or the onset or worsening of extrapyramidal symptoms (as measured by the Extrapyramidal Symptom Rating Scale A score) compared with placebo.
Additionally, the sNDA includes positive efficacy data from 2 placebo-controlled studies (in patients with Alzheimer disease psychosis and Parkinson disease psychosis), along with safety and tolerability data from completed and ongoing studies in over 1500 patients.
A Prescription Drug User Fee Act (PDUFA) action date of April 3, 2021 has been set for this application. If approved, pimavanserin would be the first therapy specifically indicated for treating patients with dementia-related psychosis.
Nuplazid is currently approved for the treatment of hallucinations and delusions associated with Parkinson disease (PD) psychosis.
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