Acadia Pharma receives CRL for Nuplazid sNDA

5 August 2022

Shares of Acadia Pharmaceuticals (Nasdaq: ACAD) were down 7.8% at $14.40 pre-market today, after the US drugmaker said it has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) regarding its supplemental New Drug Application (sNDA) for Nuplazid (pimavanserin) for the treatment of hallucinations and delusions associated with Alzheimer’s disease psychosis (ADP).

The decision comes after the FDA’s Psychopharmacologic Drugs Advisory Committee (PDAC) in June voted 9 to 3, noting that the evidence presented does not support a conclusion that pimavanserin is effective for the treatment of hallucinations and delusions in the ADP population.

It is the second time trying for Acadia to expand the indication for pimavanserin, which in April 2021 received a Complete Response Letter (CRL) from the FDA in relation to its application for dementia-related psychosis.

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