FDA Rejects Pimavanserin sNDA for Alzheimer Disease Psychosis

The sNDA for Alzheimer disease psychosis included data from the phase 3 HARMONY and phase 2 Study-019 trials.

The Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Acadia Pharmaceuticals regarding the supplemental New Drug Application (sNDA) for pimavanserin for the treatment of hallucinations and delusions associated with Alzheimer disease psychosis (ADP).

Following the resubmitted sNDA in February 2022, the FDA’s Psychopharmacologic Drugs Advisory Committee voted 3 “yes” and 9 “no”  on whether the available evidence supports the conclusion that pimavanserin is effective for the treatment of hallucinations and delusions associated with Alzheimer disease (AD) psychosis.

Pimavanserin, an atypical antipsychotic, is currently marketed under the brand name Nuplazid® and is approved for the treatment of hallucinations and delusions associated with Parkinson disease psychosis (PDD). The sNDA for Alzheimer disease psychosis included data from the phase 3 HARMONY (ClinicalTrials.gov Identifier: NCT03325556) and phase 2 Study-019 (ClinicalTrials.gov Identifier: NCT02035553) trials.

In the CRL, the FDA noted that the sNDA could not be approved in its present form stating study limitations in the interpretability of the Study 019 data. The FDA has recommended for the Company to conduct an additional trial for ADP. Moreover, the FDA stated that the positive treatment effect of pimavanserin on dementia-related psychosis in the HARMONY study “appeared to be driven by the robustly positive results in the Parkinson’s disease dementia subgroup.”

“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,” said Steve Davis, Acadia Pharmaceuticals CEO. “We want to express our gratitude to all of the patients, their families and investigators who have participated in our clinical trials.”

Reference

Acadia Pharmaceuticals receives Complete Response Letter from US FDA for supplemental New Drug Application for pimavanserin for the treatment of hallucinations and delusions associated with Alzheimer’s disease psychosis. News release. Acadia Pharmaceuticals Inc. Accessed August 5, 2022. https://www.businesswire.com/news/home/20220804006095/en/Acadia-Pharmaceuticals-Receives-Complete-Response-Letter-from-U.S.-FDA-for-Supplemental-New-Drug-Application-for-Pimavanserin-for-the-Treatment-of-Hallucinations-and-Delusions-Associated-with-Alzheimer%E2%80%99s-Disease-Psychosis

This article originally appeared on MPR