FDA rejects expanded use of Nuplazid for Alzheimer’s-related psychosis

The FDA has declined to approve a supplemental new drug application for the expanded use of Nuplazid to treat psychosis related to Alzheimer's disease.

According to a release from Acadia Pharmaceuticals, the FDA concluded there were limitations in the interpretability of Acadia’s antipsychotic drug study for Nuplazid (pimavanserin, Acadia) and an additional study would be required.

The decision is another blow to Acadia, after the Psychopharmacologic Drugs Advisory Committee voted nine to three on June 20 that available data did not support the conclusion that pimavanserin was effective for treatment of AD-related hallucinations and delusions.

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

This was Acadia's second attempt to secure approval for expanded use of pimavanserin. In April 2021, the FDA issued a complete response letter to Acadia, stating its clinical trial data was not sufficient to support approval of pimavanserin in patients with dementia-related psychosis. Acadia resubmitted its application in February, focusing instead on Alzheimer's patients.

The drug had already received approval in 2016 for a similar indication in patients with Parkinson's disease.