Acadia Pharmaceuticals has submitted a supplemental New Drug Application (sNDA) to the Food and Drug Administration (FDA) for pimavanserin (Nuplazid®) for the treatment of hallucinations and delusions associated with dementia-related psychosis.
The sNDA is supported by data from the double-blind, placebo-controlled phase 3 HARMONY trial that evaluated the efficacy and safety of pimavanserin, an atypical antipsychotic, in the treatment of hallucinations and delusions associated with dementia-related psychosis. Patients who were stabilized after 12 weeks of open-label pimavanserin treatment (n=351) were then randomized into a double-blind period of the study to continue pimavanserin or switch to placebo; they were followed for up to 26 weeks or until a relapse of psychosis occurred. The primary end point of the study was time to relapse in the double-blind period (defined as significant worsening of dementia-related psychosis after prior stabilization).
Results showed that treatment with pimavanserin significantly reduced the risk of relapse by 2.8 fold 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. Compared with placebo, pimavanserin 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).
In addition, 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.
Nuplazid is currently approved for the treatment of hallucinations and delusions associated with Parkinson disease (PD) psychosis.
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