Home » FDA Accepts Acadia’s NDA for Nuplazid for Dementia-Related Psychosis
FDA Accepts Acadia’s NDA for Nuplazid for Dementia-Related Psychosis
July 22, 2020
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.
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