Negative FDA AdCom vote for Acadia's Nuplazid

The US Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) meeting to discuss the case for approval of pimavanserin for the treatment of hallucinations and delusions associated with Alzheimer’s disease psychosis (ADP) resulted in a decisive negative vote of 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.

This is not a surprise, as briefing documents on the drug, marketed by Acadia Pharmaceuticals (Nasdaq: ACAD) as Nuplazid for the treatment of Parkinson’s-related psychosis, suggested a likely difficult path.

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.