The U.S. Food and Drug Administration declined to approve the expansion of Acadia Pharmaceuticals Inc’s ( ACAD.O ) antipsychotic drug to treat psychosis associated with Alzheimer’s disease, the company said.
The health regulator concluded that there were limitations in the interpretation of the Acadia antipsychotic drug study and, the company said, more research would be needed.
The US regulator’s decision comes about a month after a panel of outside advisers voted 9 to 3 that the available data did not support a finding that the drug pimovanserin is effective in treating hallucinations and delusions in Alzheimer’s disease.
“We are disappointed with this result. “The treatment of Alzheimer’s disease psychosis continues to be an area of ​​unmet need for which there is no approved therapy,” said Acadia Chief Executive Officer Steve Davis.
It was Acadia’s second attempt to get approval to expand the drug’s use. In April 2021, the FDA told Acadia that its clinical trial data were insufficient to support approval of pimavanserin in patients with dementia-related psychosis.
The company reapplied in February with a focus on Alzheimer’s patients.
The drug, sold under the brand name Nuplazid, is already approved for similar indications in patients with Parkinson’s disease and generated $484 million in sales last year.
