FDA Accepts Acadia’s NDA for Nuplazid for Dementia-Related Psychosis

The FDA has accepted Acadia Pharmaceuticals’ supplemental new drug application (sNDA) for anti-psychotic Nuplazid (pimavanserin) to treat hallucinations and delusions associated with dementia-related psychosis.

Approval of the drug would make Nuplazid the first and only treatment for dementia-related pyschosis. The sNDA is based on the results of a phase 3 clinical trial in which Nuplazid reduced the risk of relapse of psychosis by 2.8-fold compared to a placebo.

The FDA is expected to make a decision on the drug by April 3, 2021.