FDA turns away Acadia's Nuplazid—again—this time in Alzheimer's disease psychosis

A little over a year ago, Acadia's Nuplazid received an FDA complete response letter in the broad indication of dementia-related psychosis. Now, the agency rejected the med in a more specific use based on concerns over its data package.

The FDA determined that it could not approve Acadia's drug to treat hallucinations and delusions associated with Alzheimer’s disease psychosis. Instead, the agency recommended Acadia run another trial.

“We are disappointed with this outcome,” Steve Davis, Acadia’s CEO, said in a statement. “The treatment of Alzheimer’s disease psychosis continues to be an area of high unmet need, for which there is no approved therapy.”

In its decision, the agency acknowledged that Nuplazid met the primary endpoint of the Harmony study in a broader psychosis population, but it flagged “limitations in the interpretability” of the results, the company said.

In that trial, Nuplazid met its primary endpoint of extending time to relapse in patients with dementia-related psychosis. The FDA last year rejected the drug in that use, with reviewers citing concerns over a lack of statistical significance in some patient subgroups. 

Nevertheless, Acadia later refiled its data for the Alzheimer's disease subgroup, but now that effort has fallen short.

Nuplazid won FDA approval in the Parkinson’s disease subgroup back in 2016. In its expansion, Acadia was trying to reach the 30% of six million Alzheimer’s disease patients in the U.S. who experience psychosis. There is no FDA-approved treatment for ADP.